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

Baxis Pharmaceuticals, Inc.

Status and phase: Not yet enrolling; Phase 3

Conditions: Bacterial Conjunctivitis

Treatments: Drug: Fusidic Acid 1%; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06911424

BXP-301

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Fusidic Acid 1%

Experimental group

Description:

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

Treatment:

Drug: Fusidic Acid 1%

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo