Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
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.
400 participants
Mar 21, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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.
Exclusion Criteria9
- Have signs and/or symptoms or a diagnosis of fungal, protozoal, or viral etiology ≤30 days prior to Visit 1.
- Have experienced signs and symptoms of bacterial conjunctivitis for >48 hours prior to Visit 1.
- Require or are expected to require use of any non-study topical ocular medication or systemic medications prior to Visit 1 as specified in the protocol as ineligible.
- Have any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
- Have a known intolerance, sensitivity or allergy to the study medications or any of their components.
- Have participated in another clinical trial ≤30 days or received another experimental drug ≤90 days prior to Visit 1.
- Have a family member or household member enrolled in this study.
- Have a condition which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
- Be an employee of or immediate family member of an employee (directly related to study conduct) at the study site.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Fusidic acid 1%
Placebo ophthalmic solution
Locations(38)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06911424