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

RecruitingPhase 3

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

Who can join

All ages · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Baxis Pharmaceuticals, Inc. · Participants: 400 · Started: Mar 21, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06911424

Locations in the U.S.

ArkansasBaxis Site 04, Little Rock
CaliforniaBaxis Site 19, La Jolla
Baxis Site 39, Long Beach
Baxis Site 31, Los Angeles
Baxis Site 38, Los Angeles
FloridaBaxis Site 34, Delray Beach
Baxis Site 11, Lake Worth
Baxis Site 37, Largo
Baxis Site 27, Lutz
Baxis Site 01, Miami
Baxis Site 28, Miami Lakes
Baxis Site 29, Palm Springs
Baxis Site 10, Tampa
GeorgiaBaxis Site 35, Union City
IllinoisBaxis Site 06, Orland Park
OregonBaxis Site 30, Gresham
South CarolinaBaxis Site 12, Charleston
Baxis Site 33, Greenville
TexasBaxis Site 08, Edinburg
Baxis Site 36, Mission
VirginiaBaxis Site 32, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.