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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: NovaBay Pharmaceuticals, Inc.

Current Primary Outcome: Microbiological Success [ Time Frame: 5 days ]

Eradication of all pre-therapy isolates


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical Cure [ Time Frame: 5 days ]

Resolution of all signs and symptoms


Original Secondary Outcome: Same as current

Information By: NovaBay Pharmaceuticals, Inc.

Dates:
Date Received: June 7, 2013
Date Started: June 2013
Date Completion:
Last Updated: May 26, 2015
Last Verified: May 2015