Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis

Launched by BAXIS PHARMACEUTICALS, INC. · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a medication called fusidic acid 1% for treating bacterial conjunctivitis, which is an infection of the eye that causes redness and discharge. The goal is to see if this medication works better than a placebo (a harmless substance with no active ingredients) in both adults and children who have been diagnosed with this condition. The trial will also look at how safe fusidic acid is when applied to the eyes.

To participate in the study, individuals must have a confirmed case of bacterial conjunctivitis in at least one eye and meet certain criteria, such as not having used any eye treatments for the infection in the past two weeks. Participants should also agree to stop using contact lenses and eye makeup during the study. The trial is not yet open for recruitment, but those interested should know that they will need to provide informed consent and follow the study requirements to ensure safety and reliable results.

Gender

ALL

Eligibility criteria

• 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.