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
Sex
ALL
Min age
—
Max age
—
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.
* 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 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.
Primary outcome measure(s)
Clinical Cure — Visit 2 (Day 4) Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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