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
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
• Be willing and able to provide informed consent and comply with the study requirements.
• Not be currently pregnant or breastfeeding. If sexually active, agree to use approved contraception for the duration of the study.
Locations
United States
Arkansas
Baxis Site 04
RECRUITING
Little Rock
California
Baxis Site 24
RECRUITING
Huntington Beach
Baxis Site 19
RECRUITING
La Jolla
Baxis Site 20
RECRUITING
Sherman Oaks
Florida
Baxis Site 22
RECRUITING
Doral
Baxis Site 11
RECRUITING
Lake Worth
Baxis Site 27
RECRUITING
Lutz
Baxis Site 01
RECRUITING
Miami
Baxis Site 03
TERMINATED
Miami
Baxis Site 13
RECRUITING
Miami Beach
Baxis Site 28
RECRUITING
Miami Lakes
Baxis Site 10
RECRUITING
Tampa
Idaho
Baxis Site 15
RECRUITING
Idaho Falls
Illinois
Baxis Site 06
RECRUITING
Orland Park
Maryland
Baxis Site 26
RECRUITING
Columbia
North Carolina
Baxis Site 05
RECRUITING
Mount Airy
Nevada
Baxis Site 21
RECRUITING
North Las Vegas
New York
Baxis Site 23
RECRUITING
Babylon
Oklahoma
Baxis Site 25
RECRUITING
Tulsa
Pennsylvania
Baxis Site 09
WITHDRAWN
Pittsburgh
South Carolina
Baxis Site 12
RECRUITING
Charleston
Texas
Baxis Site 08
RECRUITING
Edinburg
Baxis Site 02
RECRUITING
Humble
Baxis Site 14
RECRUITING
Kingwood
Utah
Baxis Site 17
RECRUITING
Layton
Baxis Site 18
RECRUITING
Layton
Baxis Site 16
RECRUITING
West Valley City
Contact Information
Primary
Director of Clinical Operations
info@baxis.com
4349808100
Time Frame
Start Date:2025-03-21
Estimated Completion Date:2025-12-22
Participants
Target number of participants:400
Treatments
Experimental: Fusidic Acid 1%
Participants will instill one drop of fusidic acid 1% per eye twice a day (BID) for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing
Placebo_comparator: Placebo
Participants will instill one drop of Placebo ophthalmic solution per eye BID for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing