Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis (NCT06911424) | Clinical Trial Compass
RecruitingPhase 3
Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
United States400 participantsStarted 2025-03-21
Plain-language 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.
Who can participate
SexALL
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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.
* 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 Criteria:
* 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 o…