NCT01877694

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: NovaBay Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Conjunctivitis

Interventions

Type	Name	Description
DRUG	Auriclosene Solution 0.3%	Ophthalmic solution dispensed as drops onto the eye
DRUG	Auriclosene Vehicle	Ophthalmic Vehicle solution dispensed as drops onto the eye

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2013-06-14
• Last updated: 2015-05-28

Locations

21 sites across 1 country: United States