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NCT Number: NCT06911424

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Baxis Site 04, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fusidic Acid 1%

Drug

Fusidic acid 1%

Placebo

Drug

Placebo ophthalmic solution

Primary outcomes

  1. Clinical Cure

    Time frame: Visit 2 (Day 4)

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

Secondary outcomes

  1. Microbial Eradication

    Time frame: Visit 2 (Day 4)

    Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.

  2. Microbial Eradication

    Time frame: Visit 3 (Day 8)

    Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.

  3. Clinical Cure

    Time frame: Visit 3 (Day 8)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Director of Clinical Operations

CONTACT

[email protected]

4349808100

Sponsors and collaborators

Lead sponsor

Baxis Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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