Status:
RECRUITING
Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
Lead Sponsor:
Baxis Pharmaceuticals, Inc.
Conditions:
Bacterial Conjunctivitis
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- 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.
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 23 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06911424
Start Date
March 21 2025
End Date
March 23 2026
Last Update
December 15 2025
Active Locations (33)
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1
Baxis Site 04
Little Rock, Arkansas, United States, 72205
2
Baxis Site 24
Huntington Beach, California, United States, 92647
3
Baxis Site 19
La Jolla, California, United States, 92037
4
Baxis Site 31
Los Angeles, California, United States, 90020