Status:
COMPLETED
Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
Lead Sponsor:
NovaBay Pharmaceuticals, Inc.
Conditions:
Bacterial Conjunctivitis
Eligibility:
All Genders
1+ years
Phase:
PHASE2
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 wi...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT01877694
Start Date
June 1 2013
End Date
January 1 2015
Last Update
May 28 2015
Active Locations (21)
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1
Birmingham, Alabama, United States, 35244
2
Phoenix, Arizona, United States, 85032
3
Anaheim, California, United States, 92804
4
Bellflower, California, United States, 90706