NCT06911424 Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
| NCT ID | NCT06911424 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Baxis Pharmaceuticals, Inc. |
| Condition | Bacterial Conjunctivitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2026-03-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-03-21 with a primary completion date of 2026-03-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 profile of fusidic acid 1% for topical ocular administration.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06911424 clinical trial?
This trial is open to participants of all sexes, studying Bacterial Conjunctivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06911424 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06911424 currently recruiting?
Yes, NCT06911424 is actively recruiting participants. Contact the research team at info@baxis.com for enrollment information.
Where is the NCT06911424 trial being conducted?
This trial is being conducted at Little Rock, United States, Huntington Beach, United States, La Jolla, United States, Long Beach, United States and 11 additional locations.
Who is sponsoring the NCT06911424 clinical trial?
NCT06911424 is sponsored by Baxis Pharmaceuticals, Inc.. The trial plans to enroll 400 participants.