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

NCT06911424 | Recruiting Phase 3 FDA Drug

• 1 other identifier: BXP-301
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 38

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.

Conditions

Bacterial Conjunctivitis

Keywords

Conjunctival Diseases; Eye Diseases; Eye Infections, Bacterial; Bacterial Infections; Infections; Eye Infections; Conjunctivitis, Bacterial; Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Clinical Cure

  Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.

  Visit 2 (Day 4)

Secondary Outcomes (3)

• Microbial Eradication

  Visit 2 (Day 4)

• Microbial Eradication

  Visit 3 (Day 8)

• Clinical Cure

  Visit 3 (Day 8)

Study Arms (2)

Fusidic Acid 1%

EXPERIMENTAL

Participants will instill one drop of fusidic acid 1% per eye twice a day (BID) for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing

Drug: Fusidic Acid 1%

Placebo

PLACEBO COMPARATOR

Participants will instill one drop of Placebo ophthalmic solution per eye BID for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing

Drug: Placebo

Interventions

Fusidic Acid 1% DRUG

Fusidic acid 1%

Fusidic Acid 1%

Placebo DRUG

Placebo ophthalmic solution

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxis Pharmaceuticals, Inc.: lead

Study Sites (38)

Baxis Site 04

Little Rock, Arkansas, 72205, United States

RECRUITING

Baxis Site 24

Huntington Beach, California, 92647, United States

WITHDRAWN

Baxis Site 19

La Jolla, California, 92037, United States

RECRUITING

Baxis Site 39

Long Beach, California, 90813, United States

RECRUITING

Baxis Site 31

Los Angeles, California, 90020, United States

RECRUITING

Baxis Site 38

Los Angeles, California, 90048, United States

RECRUITING

Baxis Site 20

Sherman Oaks, California, 91423, United States

TERMINATED

Baxis Site 34

Delray Beach, Florida, 33484, United States

RECRUITING

Baxis Site 22

Doral, Florida, 33172, United States

TERMINATED

Baxis Site 11

Lake Worth, Florida, 33460, United States

RECRUITING

Baxis Site 37

Largo, Florida, 33773, United States

RECRUITING

Baxis Site 27

Lutz, Florida, 33549, United States

RECRUITING

Baxis Site 01

Miami, Florida, 33155, United States

RECRUITING

Baxis Site 03

Miami, Florida, 33176, United States

TERMINATED

Baxis Site 13

Miami Beach, Florida, 33140, United States

TERMINATED

Baxis Site 28

Miami Lakes, Florida, 33014, United States

RECRUITING

Baxis Site 29

Palm Springs, Florida, 33461, United States

RECRUITING

Baxis Site 10

Tampa, Florida, 33613, United States

RECRUITING

Baxis Site 35

Union City, Georgia, 30291, United States

RECRUITING

Baxis Site 15

Idaho Falls, Idaho, 83404, United States

TERMINATED

Baxis Site 06

Orland Park, Illinois, 60462, United States

RECRUITING

Baxis Site 26

Columbia, Maryland, 21045, United States

WITHDRAWN

Baxis Site 21

North Las Vegas, Nevada, 89030, United States

TERMINATED

Baxis Site 23

Babylon, New York, 11702, United States

WITHDRAWN

Baxis Site 05

Mount Airy, North Carolina, 27030, United States

TERMINATED

Baxis Site 25

Tulsa, Oklahoma, 74133, United States

WITHDRAWN

Baxis Site 30

Gresham, Oregon, 97030, United States

RECRUITING

Baxis Site 09

Pittsburgh, Pennsylvania, 15227, United States

WITHDRAWN

Baxis Site 12

Charleston, South Carolina, 29414, United States

RECRUITING

Baxis Site 33

Greenville, South Carolina, 29607, United States

RECRUITING

Baxis Site 08

Edinburg, Texas, 78539, United States

RECRUITING

Baxis Site 02

Humble, Texas, 77338, United States

TERMINATED

Baxis Site 14

Kingwood, Texas, 77345, United States

TERMINATED

Baxis Site 36

Mission, Texas, 78572, United States

RECRUITING

Baxis Site 17

Layton, Utah, 84041, United States

TERMINATED

Baxis Site 18

Layton, Utah, 84041, United States

TERMINATED

Baxis Site 16

West Valley City, Utah, 84120, United States

WITHDRAWN

Baxis Site 32

Charlottesville, Virginia, 22902, United States

RECRUITING

MeSH Terms

Conditions

Conjunctivitis, Bacterial; Conjunctival Diseases; Eye Diseases; Eye Infections, Bacterial; Bacterial Infections; Infections; Eye Infections; Conjunctivitis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Central Study Contacts

Director of Clinical Operations

CONTACT

4349808100; info@baxis.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All study staff (Sponsor, Site and Contract Research Organization (CRO)) involved in the day to day activities of the study are masked. Each site will have a designated unmasked dosing coordinator and the Sponsor/CRO will have an unmasked team member(s) as well, who is not involved in study conduct (e.g., for investigational product or statistical activities that require an unmasked individual).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 4, 2025
• Study Start: March 21, 2025
• Primary Completion: March 16, 2026
• Study Completion: March 23, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)