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Effect of Fusidic Acid on 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

Phase 3 Interventional Baxis Pharmaceuticals, Inc. · NCT06911424

This study is testing if a new eye drop containing fusidic acid can work better than a fake treatment for bacterial conjunctivitis in both adults and children.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
SexAll
SponsorBaxis Pharmaceuticals, Inc. Industry-sponsored
Locations38 sites (Little Rock, Arkansas and 37 other locations)
Trial IDNCT06911424 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to demonstrate that fusidic acid 1% is more effective than a placebo in treating bacterial conjunctivitis in both adults and children. Participants will be diagnosed with bacterial conjunctivitis confirmed by specific ocular discharge and redness. The study will also assess the safety profile of fusidic acid for topical use in the eyes. Eligible participants must not have received any ocular treatments for conjunctivitis within the last 14 days and must agree to certain restrictions during the study.

Who should consider this trial

Good fit: Ideal candidates include individuals with a confirmed diagnosis of bacterial conjunctivitis who meet specific inclusion criteria.

Not a fit: Patients with conjunctivitis caused by viral, fungal, or protozoal infections will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients suffering from bacterial conjunctivitis.

How similar studies have performed: Previous studies have shown positive outcomes with similar antibiotic treatments for bacterial conjunctivitis, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Little Rock, Arkansas and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bacterial ConjunctivitisConjunctival DiseasesEye DiseasesEye Infections, BacterialBacterial InfectionsInfectionsEye InfectionsConjunctivitis, Bacterial
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.