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

Description

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.

Conditions

Bacterial Conjunctivitis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Bacterial Conjunctivitis
Intervention / Treatment

-

Contacts and Locations

Little Rock

Baxis Site 04, Little Rock, Arkansas, United States, 72205

Huntington Beach

Baxis Site 24, Huntington Beach, California, United States, 92647

La Jolla

Baxis Site 19, La Jolla, California, United States, 92037

Sherman Oaks

Baxis Site 20, Sherman Oaks, California, United States, 91423

Doral

Baxis Site 22, Doral, Florida, United States, 33172

Lake Worth

Baxis Site 11, Lake Worth, Florida, United States, 33460

Miami Beach

Baxis Site 13, Miami Beach, Florida, United States, 33140

Miami

Baxis Site 01, Miami, Florida, United States, 33155

Miami

Baxis Site 03, Miami, Florida, United States, 33176

Tampa

Baxis Site 10, Tampa, Florida, United States, 33613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baxis Pharmaceuticals, Inc.,

Study Record Dates

2025-12-22