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NCT06911424PHASE3Recruiting

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

Baxis Pharmaceuticals, Inc.

Start Date

3/21/2025

Completion Date

3/23/2026

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

Age Range: No minimum to No maximum

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.

Interventions

DRUG

Fusidic Acid 1%

DRUG

Placebo

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Conditions

Bacterial Conjunctivitis

Locations

Baxis Site 04

Little Rock, Arkansas 72205

United States

Baxis Site 24

Huntington Beach, California 92647

United States

Baxis Site 19

La Jolla, California 92037

United States

Baxis Site 39

Long Beach, California 90813

United States

Baxis Site 31

Los Angeles, California 90020

United States

Baxis Site 38

Los Angeles, California 90048

United States

Baxis Site 20

Sherman Oaks, California 91423

United States

Baxis Site 34

Delray Beach, Florida 33484

United States

Baxis Site 22

Doral, Florida 33172

United States

Baxis Site 11

Lake Worth, Florida 33460

United States

Baxis Site 37

Largo, Florida 33773

United States

Baxis Site 27

Lutz, Florida 33549

United States

Baxis Site 01

Miami, Florida 33155

United States

Baxis Site 03

Miami, Florida 33176

United States

Baxis Site 13

Miami Beach, Florida 33140

United States

Baxis Site 28

Miami Lakes, Florida 33014

United States

Baxis Site 29

Palm Springs, Florida 33461

United States

Baxis Site 10

Tampa, Florida 33613

United States

Baxis Site 35

Union City, Georgia 30291

United States

Baxis Site 15

Idaho Falls, Idaho 83404

United States

Baxis Site 06

Orland Park, Illinois 60462

United States

Baxis Site 26

Columbia, Maryland 21045

United States

Baxis Site 21

North Las Vegas, Nevada 89030

United States

Baxis Site 23

Babylon, New York 11702

United States

Baxis Site 05

Mount Airy, North Carolina 27030

United States

Baxis Site 25

Tulsa, Oklahoma 74133

United States

Baxis Site 30

Gresham, Oregon 97030

United States

Baxis Site 09

Pittsburgh, Pennsylvania 15227

United States

Baxis Site 12

Charleston, South Carolina 29414

United States

Baxis Site 33

Greenville, South Carolina 29607

United States

Baxis Site 08

Edinburg, Texas 78539

United States

Baxis Site 02

Humble, Texas 77338

United States

Baxis Site 14

Kingwood, Texas 77345

United States

Baxis Site 36

Mission, Texas 78572

United States

Baxis Site 17

Layton, Utah 84041

United States

Baxis Site 18

Layton, Utah 84041

United States

Baxis Site 16

West Valley City, Utah 84120

United States

Baxis Site 32

Charlottesville, Virginia 22902

United States