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An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

Primary Purpose

Adenoviral Conjunctivitis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-46383A Ophthalmic Solution
AL-46383A Ophthalmic Solution Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoviral Conjunctivitis focused on measuring pink eye, eye infection, conjunctivitis

Eligibility Criteria

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

Inclusion Criteria:

  • At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.
  • Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
  • Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
  • Must agree to comply with the visit schedule and other requirements of the study.
  • Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Sub-epithelial infiltrates at the Day 1 visit in either eye.
  • Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
  • Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
  • Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.
  • Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.
  • Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.
  • History of active uveitis or iritis in either eye.
  • History of corneal transplant in either eye.
  • Presence of nasolacrimal duct obstruction at Day 1.
  • Use of specified prohibited medications.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    AL-46383A

    Vehicle

    Arm Description

    AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days

    AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days

    Outcomes

    Primary Outcome Measures

    Sustained microbiological success at Day 5 or Day 7

    Secondary Outcome Measures

    Time to sustained microbiological success

    Full Information

    First Posted
    May 8, 2009
    Last Updated
    May 7, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00901693
    Brief Title
    An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    Internal business decision
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenoviral Conjunctivitis
    Keywords
    pink eye, eye infection, conjunctivitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    452 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-46383A
    Arm Type
    Experimental
    Arm Description
    AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days
    Intervention Type
    Drug
    Intervention Name(s)
    AL-46383A Ophthalmic Solution
    Intervention Type
    Drug
    Intervention Name(s)
    AL-46383A Ophthalmic Solution Vehicle
    Primary Outcome Measure Information:
    Title
    Sustained microbiological success at Day 5 or Day 7
    Time Frame
    Up to Day 18
    Secondary Outcome Measure Information:
    Title
    Time to sustained microbiological success
    Time Frame
    Up to Day 18

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist. Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye. Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC). Must agree to comply with the visit schedule and other requirements of the study. Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Sub-epithelial infiltrates at the Day 1 visit in either eye. Corneal opacity or any corneal abnormality at the Day 1 visit in either eye. Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction. Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit. Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit. Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation. History of active uveitis or iritis in either eye. History of corneal transplant in either eye. Presence of nasolacrimal duct obstruction at Day 1. Use of specified prohibited medications. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sally Scheib
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

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