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FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

Primary Purpose

Acute Adenoviral Conjunctivitis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FST-100 Ophthalmic Suspension
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Adenoviral Conjunctivitis

Eligibility Criteria

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

Inclusion Criteria:

  • Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge.
  • Clinical suspicion of adenoviral etiology.
  • At least three (3) years of age.
  • Subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent.

  • Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis:

    1. conjunctival injection/inflammation, and
    2. conjunctival discharge/exudates.

Exclusion Criteria:

  • Conjunctivitis longer than 7 days after initial ocular symptoms.
  • Corneal ulcer, endophthalmitis, or any other confounding infection of the eye.
  • Patients taking ocular anti-inflammatory medications on a chronic basis.
  • Active herpes ocular infection.
  • Known or suspected pregnancy.
  • Known allergy to PVP-I.
  • Known allergy to dexamethasone.
  • Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders").

Sites / Locations

  • Wolstan and Goldberg Eye Associates
  • Colorado Eye Associates
  • Eye Center
  • The Center for Excellence in Eye
  • Ocean Ophthalmology
  • The Midwest Center for Sight
  • Silverstein Eye Centers
  • St. Johns Clinic
  • Ophthalmic Consultants PC The New York Eye and Ear Infirmary
  • Columbus Ophthalmology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FST-100 Ophthalmic Suspension

Vehicle

Arm Description

FST-100 (PVP-I 0.4% and dexamethasone 0.1%)

Outcomes

Primary Outcome Measures

Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.

Secondary Outcome Measures

Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.

Full Information

First Posted
July 15, 2009
Last Updated
August 22, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00941486
Brief Title
FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis
Official Title
A Randomized, Masked, Vehicle-controlled Clinical Trial to Assess the Safety and Efficacy of PVP-I (0.4%)/Dexamethasone (0.1%) Ophthalmic Suspension (Foresight Biotherapeutics, Inc) in the Treatment of Acute Adenoviral Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Study Start Date
June 30, 2009 (Actual)
Primary Completion Date
June 30, 2010 (Actual)
Study Completion Date
June 30, 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy of FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FST-100 Ophthalmic Suspension
Arm Type
Experimental
Arm Description
FST-100 (PVP-I 0.4% and dexamethasone 0.1%)
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
FST-100 Ophthalmic Suspension
Intervention Description
FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A regimen of 2 drops 4 times a day while awake for 5 days.
Primary Outcome Measure Information:
Title
Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge. Clinical suspicion of adenoviral etiology. At least three (3) years of age. Subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent. Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis: conjunctival injection/inflammation, and conjunctival discharge/exudates. Exclusion Criteria: Conjunctivitis longer than 7 days after initial ocular symptoms. Corneal ulcer, endophthalmitis, or any other confounding infection of the eye. Patients taking ocular anti-inflammatory medications on a chronic basis. Active herpes ocular infection. Known or suspected pregnancy. Known allergy to PVP-I. Known allergy to dexamethasone. Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders").
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Wolstan and Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Colorado Eye Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Eye Center
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
The Center for Excellence in Eye
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Ocean Ophthalmology
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
The Midwest Center for Sight
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
St. Johns Clinic
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Ophthalmic Consultants PC The New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Columbus Ophthalmology Associates
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States

12. IPD Sharing Statement

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FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

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