Recruiting

Phase 3

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

Sponsor:

Baxis Pharmaceuticals, Inc.

Code:

NCT06911424

Conditions

Bacterial Conjunctivitis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Fusidic Acid 1%

Placebo

Study Details

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

Study ID

NCT06911424

Start date

Mar 21, 2025

Status verified date

Dec, 2025

Completion date

Mar 23, 2026

Anticipated

Primary completion date

Mar 16, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fusidic Acid 1%

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

placebo comparator: Placebo

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

Interventions

Fusidic Acid 1%

Fusidic acid 1%

Placebo

Placebo ophthalmic solution

Primary outcome measure

Clinical Cure [ Time Frame: Visit 2 (Day 4) ]

Central Contacts and Locations

Central contacts

Director of Clinical Operations

4349808100 info@baxis.com

Locations

Baxis Site 04

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information