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

Phase 2

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: Auriclosene Vehicle; Drug: Auriclosene Solution 0.3%

• Registration Number: NCT01877694
• Lead Sponsor: NovaBay Pharmaceuticals, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-14
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auriclosene Vehicle	Auriclosene Vehicle	Dosed QID for 4 days
Auriclosene Solution 0.3%	Auriclosene Solution 0.3%	Dosed QID for 4 Days

Primary Outcome Measures

Name	Time	Method
Microbiological Success	5 days	Eradication of all pre-therapy isolates

Secondary Outcome Measures

Name	Time	Method
Clinical Cure	5 days	Resolution of all signs and symptoms