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Clinical Trials in the USA / NCT06911424
Recruiting Phase 3

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

NCT06911424 · tracked via the Priya Life Science USA tracker
Sponsor
Baxis Pharmaceuticals, Inc.
Phase
Phase 3
Started
2025-03-21
Last updated
2026-03-17

Condition(s) studied

Bacterial Conjunctivitis

Investigational drug(s) / intervention(s)

Fusidic Acid 1%Placebo

Fusidic Acid 1%: Fusidic acid 1%

Placebo: Placebo ophthalmic solution

Study 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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Baxis Site 04 Little Rock Arkansas Recruiting
Baxis Site 24 Huntington Beach California Withdrawn
Baxis Site 19 La Jolla California Recruiting
Baxis Site 39 Long Beach California Recruiting
Baxis Site 31 Los Angeles California Recruiting
Baxis Site 38 Los Angeles California Recruiting
Baxis Site 20 Sherman Oaks California Terminated
Baxis Site 34 Delray Beach Florida Recruiting
Baxis Site 22 Doral Florida Terminated
Baxis Site 11 Lake Worth Florida Recruiting
Baxis Site 37 Largo Florida Recruiting
Baxis Site 27 Lutz Florida Recruiting
Baxis Site 01 Miami Florida Recruiting
Baxis Site 03 Miami Florida Terminated
Baxis Site 13 Miami Beach Florida Terminated
Baxis Site 28 Miami Lakes Florida Recruiting
Baxis Site 29 Palm Springs Florida Recruiting
Baxis Site 10 Tampa Florida Recruiting
Baxis Site 35 Union City Georgia Recruiting
Baxis Site 15 Idaho Falls Idaho Terminated
Baxis Site 06 Orland Park Illinois Recruiting
Baxis Site 26 Columbia Maryland Withdrawn
Baxis Site 21 North Las Vegas Nevada Terminated
Baxis Site 23 Babylon New York Withdrawn
Baxis Site 05 Mount Airy North Carolina Terminated
Baxis Site 25 Tulsa Oklahoma Withdrawn
Baxis Site 30 Gresham Oregon Recruiting
Baxis Site 09 Pittsburgh Pennsylvania Withdrawn
Baxis Site 12 Charleston South Carolina Recruiting
Baxis Site 33 Greenville South Carolina Recruiting
Baxis Site 08 Edinburg Texas Recruiting
Baxis Site 02 Humble Texas Terminated
Baxis Site 14 Kingwood Texas Terminated
Baxis Site 36 Mission Texas Recruiting
Baxis Site 17 Layton Utah Terminated
Baxis Site 18 Layton Utah Terminated
Baxis Site 16 West Valley City Utah Withdrawn
Baxis Site 32 Charlottesville Virginia Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06911424 on ClinicalTrials.gov ↗ ← All trials in the USA