Clinical trial NCT06911424: Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Keywords: Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Infections
Eye Infections
Conjunctivitis, Bacterial
Conjunctivitis
Lead sponsor: Baxis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Clinical Cure
timeFrame: Visit 3 (Day 8)
Secondary outcomes:
measure: Microbial Eradication
timeFrame: Visit 3 (Day 8)
measure: Microbial Eradication
timeFrame: Visit 2 (Day 4)
measure: Clinical Cure
timeFrame: Visit 2 (Day 4)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baxis Site 04
state: Arkansas
city: Huntington Beach
country: United States
facility: Baxis Site 24
state: California
city: La Jolla
country: United States
facility: Baxis Site 19
state: California
city: Sherman Oaks
country: United States
facility: Baxis Site 20
state: California
city: Doral
country: United States
facility: Baxis Site 22
state: Florida
city: Lake Worth
country: United States
facility: Baxis Site 11
state: Florida
city: Miami Beach
country: United States
facility: Baxis Site 13
state: Florida
city: Miami
country: United States
facility: Baxis Site 01
state: Florida
city: Miami
country: United States
facility: Baxis Site 03
state: Florida
city: Tampa
country: United States
facility: Baxis Site 10
state: Florida
city: Idaho Falls
country: United States
facility: Baxis Site 15
state: Idaho
city: Orland Park
country: United States
facility: Baxis Site 06
state: Illinois
city: Columbia
country: United States
facility: Baxis Site 26
state: Maryland
city: North Las Vegas
country: United States
facility: Baxis Site 21
state: Nevada
city: Babylon
country: United States
facility: Baxis Site 23
state: New York
city: Mount Airy
country: United States
facility: Baxis Site 05
state: North Carolina
city: Tulsa
country: United States
facility: Baxis Site 25
state: Oklahoma
city: Pittsburgh
country: United States
facility: Baxis Site 09
state: Pennsylvania
city: Charleston
country: United States
facility: Baxis Site 12
state: South Carolina
city: Edinburg
country: United States
facility: Baxis Site 08
state: Texas
city: Humble
country: United States
facility: Baxis Site 02
state: Texas
city: Kingwood
country: United States
facility: Baxis Site 14
state: Texas
city: Layton
country: United States
facility: Baxis Site 17
state: Utah
city: Layton
country: United States
facility: Baxis Site 18
state: Utah
city: West Valley
country: United States
facility: Baxis Site 16
state: Utah
Study officials:
References: