Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.

Detailed Description
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This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% (Auriclosene) and Auriclosene Vehicle (Vehicle). Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits: Visit 1: Screening, Day 1 Visit 2: Day 3 (±1) Visit 3: Day 5 (+1) Test of Cure/Exit IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit. Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.

Official Title
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A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: Auriclosene Solution 0.3%
* Drug: Auriclosene Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 year of age and older Bulbar conjunctival injection Conjunctival discharge/exudate Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less Other inclusion criteria per protocol Exclusion Criteria: Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical diagnosis Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment Other exclusion criteria per protocol

Ages Eligible for Study
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Minimum Age: 1 Year

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auriclosene Solution 0.3%<br>Dosed QID for 4 Days | Drug: Auriclosene Solution 0.3%<br>* Ophthalmic solution dispensed as drops onto the eye<br>* Other names: NVC-422;|
| Placebo Comparator: Auriclosene Vehicle<br>Dosed QID for 4 days | Drug: Auriclosene Vehicle<br>* Ophthalmic Vehicle solution dispensed as drops onto the eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Success | Eradication of all pre-therapy isolates | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure | Resolution of all signs and symptoms | 5 days | 

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