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

Overview

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.

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

Interventions

Eligibility

Locations (21)

Outcomes