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

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

Conditions
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Adenoviral Conjunctivitis

Intervention / Treatment
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* Drug: AL-46383A Ophthalmic Solution
* Drug: AL-46383A Ophthalmic Solution Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-46383A<br>AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days | Drug: AL-46383A Ophthalmic Solution<br> <br> |
| Placebo Comparator: Vehicle<br>AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days | Drug: AL-46383A Ophthalmic Solution Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained microbiological success at Day 5 or Day 7 |  | Up to Day 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sustained microbiological success |  | Up to Day 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pink eye, eye infection, conjunctivitis