A Phase 3 Randomized, Multi-Center, Placebo-Controlled, Masked Study to Evaluate the Clinical Efficacy and Safety of Fusidic Acid 1% Viscous Topical Antibiotic Eye Drops for the Treatment of Suspected Bacterial Conjunctivitis
Baxis Pharmaceuticals, Inc.
Summary
The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Main Inclusion Criteria: * Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye, confirmed by the presence of purulent or mucopurulent ocular discharge and a grade ≥ 1 on the modified Validated Bulbar Redness (VBR) conjunctival redness scale. * Have not received any ocular treatment for conjunctivitis, aside from eyelid hygiene, ≤14 days prior to Visit 1. * Have a negative viral conjunctivitis test in both eyes. * Agree to discontinue use of eye/eyelid cosmetics during study participation. * Agree to discontinue use of contact lenses during study participation. *…
Interventions
- DrugFusidic Acid 1%
Fusidic acid 1%
- DrugPlacebo
Placebo ophthalmic solution
Locations (38)
- Baxis Site 04Little Rock, Arkansas
- Baxis Site 24Huntington Beach, California
- Baxis Site 19La Jolla, California
- Baxis Site 39Long Beach, California
- Baxis Site 31Los Angeles, California
- Baxis Site 38Los Angeles, California