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Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

Primary Purpose

Bacterial Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SHP640
PVP-I 0.6%
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
  • Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
  • Participants of any age at Visit 1 (Note: participants less than (<) 3 months of age at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37 weeks gestational age at birth).
  • Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
  • Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:

    1. Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (<=) 4 days prior to Visit 1
    2. Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
    3. Ocular conjunctival discharge: a grade of >= 1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale
  • Be willing to discontinue contact lens wear for the duration of the study.
  • Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker, 2016; American Academy of Pediatrics, 2016). The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. If not done, child should be able to fixate on and follow a moving object, except participants < 2 months of age who have not yet developed this ability. Participants < 2 months will be enrolled at the discretion of investigator.
  • Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion Criteria:

  • Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
  • Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
  • Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
  • Prior enrollment in a FST-100 or SHP640 clinical study.
  • Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
  • Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study.
  • Have a preplanned overnight hospitalization during the period of the study.
  • Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis.
  • Have active or a history of ocular herpes.
  • Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-bacterial ocular infection (eg, viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.
  • Neonates or infants (ie, participants less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
  • Neonates or infants (ie, participants less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
  • Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
  • Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
  • Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma or be a glaucoma suspect.
  • Have any known clinically significant optic nerve defects.
  • Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
  • Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period.
  • Have used any topical ocular or systemic antibiotics within <= 7 days of enrollment.
  • Have used any topical ocular non-steroidal anti-inflammatory drugs within <= 1 day of enrollment.
  • Have used any topical ophthalmic steroids in the last <= 14 days.
  • Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the periocular area.
  • Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.
  • Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
  • Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may affect the study parameters, per investigator's discretion.
  • Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.
  • Within 30 days prior to the first dose of investigational product:

    1. Have used an investigational product or device, or
    2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.

Sites / Locations

  • Arizona Eye Center
  • Cornea and Cataract Consultants of Arizona
  • M&M Eye Institute
  • Schwartz Laser Eye Center
  • Walman Eye Center
  • Milton M. Hom, OD, FAAO
  • Clark S Tsai Eye Center
  • Lugene Eye Institute Inc
  • Mark B. Kislinger, MD, Inc.
  • Inland Eye Specialists
  • Lakeside Vision Center
  • Hull Eye Center
  • Eye Physicians of Long Beach
  • Oxford Optical
  • Sok H. Nam, M.D. Inc.
  • University of Southern California
  • Macy Eye Center
  • North Valley Eye Medical Group Inc
  • North Bay Eye Associates, Inc.
  • Arch Health Partners
  • Martel Eye Medical Group
  • Shasta Eye Medical Group, Inc.
  • Clinical Trials Research
  • Sacramento Eye Consultants
  • WCCT Global (PH 1 Unit)
  • East West Eye Institute
  • Wolstan & Goldberg Eye Associates
  • Specialty Eye Care
  • Danbury Eye Physicians and Surgeons
  • Ophthalmic Consultants of Connecticut
  • Windham Eye Group
  • The Eye Associates of Manatee, LLP
  • Bruce A. Segal, MD, PA
  • South Florida Vision
  • Bowden Eye & Associates
  • Shettle Eye Research, Inc.
  • Millenium Clinical Research
  • Millennium Clinical Research, Inc.
  • South Florida Research Center Inc.
  • Bascom Palmer Eye Institute
  • Lorites Medical Group
  • Pediatric & Adult Research Center, LLC
  • Medsol Clinical Research Center
  • Score Physician Alliance, LLC
  • East Florida Eye Institute
  • Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
  • Logan Ophthalmic Research, LLC
  • International Research Center
  • Eye Care Centers Management, Inc.
  • Jenkins Eye Care
  • Saltzer Medical Group
  • Wohl Eye Center
  • Jackson Eye
  • Illinois Eye Center
  • MediSphere Medical Research Center, LLC
  • Midwest Cornea Associates, LLC
  • Sabates Eye Centers
  • Kannarr Eye Care
  • Cincinnati Eye Institute
  • Koffler Vision Group
  • Kentucky Eye Institute
  • The Eye Care Institute
  • Dr. Haider Eye Care
  • Senior Health Services
  • Baker, Carl W
  • Lakeview Vision
  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
  • Eye Center Northeast
  • Massachusetts Eye and Ear Infirmary
  • NECCR PrimaCare Research
  • Shire Call Center
  • Clinical Eye Research of Boston
  • Minnesota Eye Consultants, P.A
  • Lifelong Vision Foundation
  • Silverstein Eye Centers
  • Moyes Eye Center
  • Washington University
  • Tekwani Vision Center
  • Ophthalmology Associates
  • Opthalmology Consultants Ltd.
  • Mercy Research
  • NV Eye Physicians
  • Wellish Vision Institute
  • Emil A. Stein, M.D., Ltd.
  • Hassman Research Institute
  • Northern New Jersey Eye Institute
  • Farkas, Kassalow, Resnick &Associates
  • Fichte, Endl& Elmer Eyecare
  • South Shore Eye Care
  • Oculus Research at Garner EyeCareCenter
  • James Branch, M.D.
  • Apex Eye Kenwood
  • Cincinnati Eye Institute
  • Apex Eye
  • Cleveland Eye Clinic
  • The Ohio State University
  • The Columbus Eye Center
  • SkyVision Centers
  • IPS Research Company*
  • Pacific Clear Vision Institute
  • Matossian Eye Associates
  • Philadelphia Eye Associates
  • UPMC Eye Center
  • Wyomissing Optometric Center
  • Bluestein Custom Vision
  • Black Hills Regional Eye Institute
  • Total Eye Care, PA
  • Eye Specialty Group
  • Nashville Vision Associates
  • Toyos Clinic
  • Eyeland Vision
  • Houston Eye Associates
  • Advanced Laser Vision & Surgical Institute
  • Lake Travis Eye & Laser Center
  • DCT- Shah Research, LLC dba Discovery Clinical Trials
  • Sun Research Institute, LLC
  • R and R Eye Research, LLC.
  • Lone Star Eye Care, P.A.
  • Ericksen Research & Development, LLC
  • Chrysalis Clinical Research
  • The Eye Institute of Utah
  • Jean Brown Research
  • Emerson Clinical Research Institute
  • Piedmont Eye Center, Inc.
  • University of Wisconsin
  • University of the Sunshine Coast Clinical Trials Centre
  • Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH
  • AKH - Medizinische Universitaet Wien
  • Vienna Institute for Research in Ocular Surgery
  • The Ottawa Hospital - General Campus, University of Ottawa Eye Institute
  • University of Waterloo School of Optometry and Vision Science
  • Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)
  • East Tallinn Central Hospital Eye Clinic
  • Tartu University Hospital
  • CHU Limoges - Hopital Dupuytren
  • SZTE Szemeszeti Klinika
  • Bugat Pal Hospital Clinexpert Gyongyos
  • Debreceni Egyetem
  • Kaposi Mór Hospital
  • Csolnoky Ferenc Korhaz
  • HaEmek Medical Center
  • Soroka University Medical Center
  • Rambam MC
  • Sharey Zedek MC
  • Rabin Medical Center-Beilinson Campus.
  • Kaplan Medical Center
  • Tel Aviv Medical Center
  • A.O.U. Policlinico San'Orsola-Malpighi
  • Centrum Medyczne Uno-Med
  • Szpital Specjalistyczny nr 1
  • Centrum Diagnostyki i Mikrochirurgii Oka LENS
  • Centrum Medyczne Uno-Med
  • Retina Sp. z o.o.
  • Emanuelli Research & Development Center, LLC
  • Centro Dotal de Investigaciones de Servicios de Salud
  • Berrocal and Associates
  • Newtown Clinical Research Centre
  • Pretoria Eye Institute
  • Into Research
  • Instituto Oftalmológico Fernández-Vega
  • Clinica Oftalmologia Gil Piña
  • Clinica Rementeria
  • Cartujavision

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

SHP640

PVP-I 0.6%

Placebo

Arm Description

Participants will instill 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.

Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days

Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.

Outcomes

Primary Outcome Measures

Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.

Secondary Outcome Measures

Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Number of Participants With Clinical Resolution
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Number of Participants With Bacterial Eradication
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.
Bulbar Conjunctival Injection Score
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Change From Baseline in the Bulbar Conjunctival Injection Score
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Ocular Conjunctival Discharge Score
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Change From Baseline in the Ocular Conjunctival Discharge Score
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Global Clinical Score
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Change From Baseline in the Global Clinical Score
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Number of Participants With Modified Clinical Resolution
Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Number of Participants With Expanded Clinical Resolution
Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time to Clinical Resolution
Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.
Number of Participants Who Used Rescue Medication
Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.

Full Information

First Posted
December 19, 2016
Last Updated
May 21, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT03004924
Brief Title
Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
Official Title
A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
753 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHP640
Arm Type
Experimental
Arm Description
Participants will instill 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Arm Title
PVP-I 0.6%
Arm Type
Active Comparator
Arm Description
Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.
Intervention Type
Drug
Intervention Name(s)
SHP640
Intervention Description
Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
Intervention Type
Drug
Intervention Name(s)
PVP-I 0.6%
Intervention Description
Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
Description
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
Description
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Time Frame
Baseline, Day 5
Title
Number of Participants With Clinical Resolution
Description
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time Frame
Day 3, 8 and 12
Title
Number of Participants With Bacterial Eradication
Description
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.
Time Frame
Day 3, 8 and 12
Title
Bulbar Conjunctival Injection Score
Description
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Time Frame
Day 3, 5, 8 and 12
Title
Change From Baseline in the Bulbar Conjunctival Injection Score
Description
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Time Frame
Baseline, Day 3, 5, 8 and 12
Title
Ocular Conjunctival Discharge Score
Description
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time Frame
Day 3, 5, 8 and 12
Title
Change From Baseline in the Ocular Conjunctival Discharge Score
Description
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time Frame
Baseline, Day 3, 5, 8 and 12
Title
Global Clinical Score
Description
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time Frame
Day 3, 5, 8 and 12
Title
Change From Baseline in the Global Clinical Score
Description
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Time Frame
Baseline, Day 3, 5, 8 and 12
Title
Number of Participants With Modified Clinical Resolution
Description
Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time Frame
Day 3, 5, 8 and 12
Title
Number of Participants With Expanded Clinical Resolution
Description
Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Time Frame
Day 3, 5, 8 and 12
Title
Time to Clinical Resolution
Description
Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.
Time Frame
Baseline to Day 12
Title
Number of Participants Who Used Rescue Medication
Description
Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.
Time Frame
Baseline to Day 12
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.
Time Frame
From start of study drug administration up to 14 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable). Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study. Participants of any age at Visit 1 (Note: participants less than (<) 3 months of age at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37 weeks gestational age at birth). Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1. Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye: Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (<=) 4 days prior to Visit 1 Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale Ocular conjunctival discharge: a grade of >= 1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale Be willing to discontinue contact lens wear for the duration of the study. Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker, 2016; American Academy of Pediatrics, 2016). The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. If not done, child should be able to fixate on and follow a moving object, except participants < 2 months of age who have not yet developed this ability. Participants < 2 months will be enrolled at the discretion of investigator. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. Exclusion Criteria: Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients. Prior enrollment in a FST-100 or SHP640 clinical study. Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site. Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study. Have a preplanned overnight hospitalization during the period of the study. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis. Have active or a history of ocular herpes. Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-bacterial ocular infection (eg, viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary. Neonates or infants (ie, participants less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin. Neonates or infants (ie, participants less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1). Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables. Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma or be a glaucoma suspect. Have any known clinically significant optic nerve defects. Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1. Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period. Have used any topical ocular or systemic antibiotics within <= 7 days of enrollment. Have used any topical ocular non-steroidal anti-inflammatory drugs within <= 1 day of enrollment. Have used any topical ophthalmic steroids in the last <= 14 days. Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the periocular area. Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1. Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study. Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may affect the study parameters, per investigator's discretion. Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplantation. Within 30 days prior to the first dose of investigational product: Have used an investigational product or device, or Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Cornea and Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
M&M Eye Institute
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
Schwartz Laser Eye Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Walman Eye Center
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Milton M. Hom, OD, FAAO
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Clark S Tsai Eye Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Lugene Eye Institute Inc
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Mark B. Kislinger, MD, Inc.
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
Lakeside Vision Center
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Facility Name
Hull Eye Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Eye Physicians of Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Oxford Optical
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States
Facility Name
Sok H. Nam, M.D. Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Macy Eye Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
North Valley Eye Medical Group Inc
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Arch Health Partners
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Shasta Eye Medical Group, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Clinical Trials Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sacramento Eye Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
WCCT Global (PH 1 Unit)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
East West Eye Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Specialty Eye Care
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Danbury Eye Physicians and Surgeons
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Ophthalmic Consultants of Connecticut
City
Meriden
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Windham Eye Group
City
Willimantic
State/Province
Connecticut
ZIP/Postal Code
06226
Country
United States
Facility Name
The Eye Associates of Manatee, LLP
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Bruce A. Segal, MD, PA
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
South Florida Vision
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Bowden Eye & Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Shettle Eye Research, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Millenium Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Millennium Clinical Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
South Florida Research Center Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Lorites Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Pediatric & Adult Research Center, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Medsol Clinical Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33948
Country
United States
Facility Name
Score Physician Alliance, LLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34494
Country
United States
Facility Name
Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Logan Ophthalmic Research, LLC
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
International Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Eye Care Centers Management, Inc.
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Jenkins Eye Care
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Saltzer Medical Group
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Wohl Eye Center
City
Bloomingdale
State/Province
Illinois
ZIP/Postal Code
60108
Country
United States
Facility Name
Jackson Eye
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Illinois Eye Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Midwest Cornea Associates, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Sabates Eye Centers
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Cincinnati Eye Institute
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Koffler Vision Group
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Kentucky Eye Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Dr. Haider Eye Care
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Senior Health Services
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Baker, Carl W
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Lakeview Vision
City
Gretna
State/Province
Louisiana
ZIP/Postal Code
70056
Country
United States
Facility Name
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Eye Center Northeast
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
NECCR PrimaCare Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Shire Call Center
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States
Facility Name
Clinical Eye Research of Boston
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Minnesota Eye Consultants, P.A
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Moyes Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Opthalmology Consultants Ltd.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Mercy Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65806
Country
United States
Facility Name
NV Eye Physicians
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Wellish Vision Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Emil A. Stein, M.D., Ltd.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Northern New Jersey Eye Institute
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079
Country
United States
Facility Name
Farkas, Kassalow, Resnick &Associates
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Fichte, Endl& Elmer Eyecare
City
Niagara Falls
State/Province
New York
ZIP/Postal Code
14304
Country
United States
Facility Name
South Shore Eye Care
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Oculus Research at Garner EyeCareCenter
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
James Branch, M.D.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Apex Eye Kenwood
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Apex Eye
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
Cleveland Eye Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Columbus Eye Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
SkyVision Centers
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
IPS Research Company*
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Pacific Clear Vision Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Matossian Eye Associates
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18902
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Wyomissing Optometric Center
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Bluestein Custom Vision
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
59101
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Nashville Vision Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Toyos Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Eyeland Vision
City
El Paso
State/Province
Texas
ZIP/Postal Code
79934
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Advanced Laser Vision & Surgical Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Lake Travis Eye & Laser Center
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
DCT- Shah Research, LLC dba Discovery Clinical Trials
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
Sun Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
R and R Eye Research, LLC.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Lone Star Eye Care, P.A.
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Ericksen Research & Development, LLC
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Chrysalis Clinical Research
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
Piedmont Eye Center, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of the Sunshine Coast Clinical Trials Centre
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Facility Name
Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AKH - Medizinische Universitaet Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Vienna Institute for Research in Ocular Surgery
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
The Ottawa Hospital - General Campus, University of Ottawa Eye Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
University of Waterloo School of Optometry and Vision Science
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Facility Name
Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)
City
Tallinn
ZIP/Postal Code
10120
Country
Estonia
Facility Name
East Tallinn Central Hospital Eye Clinic
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51010
Country
Estonia
Facility Name
CHU Limoges - Hopital Dupuytren
City
Limoges
State/Province
Haute Vienne
ZIP/Postal Code
87042
Country
France
Facility Name
SZTE Szemeszeti Klinika
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Bugat Pal Hospital Clinexpert Gyongyos
City
Gyongyos
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Kaposi Mór Hospital
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18341
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam MC
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Sharey Zedek MC
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus.
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
A.O.U. Policlinico San'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Centrum Medyczne Uno-Med
City
Krakow
State/Province
Malopolska
ZIP/Postal Code
31-070
Country
Poland
Facility Name
Szpital Specjalistyczny nr 1
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka LENS
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Facility Name
Centrum Medyczne Uno-Med
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Retina Sp. z o.o.
City
Warszawa
ZIP/Postal Code
01 -364
Country
Poland
Facility Name
Emanuelli Research & Development Center, LLC
City
Arecibo
ZIP/Postal Code
00613
Country
Puerto Rico
Facility Name
Centro Dotal de Investigaciones de Servicios de Salud
City
Carolina
ZIP/Postal Code
00984
Country
Puerto Rico
Facility Name
Berrocal and Associates
City
San Juan
ZIP/Postal Code
00907
Country
Puerto Rico
Facility Name
Newtown Clinical Research Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Pretoria Eye Institute
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0082
Country
South Africa
Facility Name
Into Research
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Instituto Oftalmológico Fernández-Vega
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33012
Country
Spain
Facility Name
Clinica Oftalmologia Gil Piña
City
Huelva
ZIP/Postal Code
21002
Country
Spain
Facility Name
Clinica Rementeria
City
Madrid
ZIP/Postal Code
28010
Country
Spain
Facility Name
Cartujavision
City
Sevilla
ZIP/Postal Code
41092
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

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