Actively Recruiting
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
Led by Baxis Pharmaceuticals, Inc. · Updated on 2026-03-17
400
Participants Needed
38
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo for treating bacterial conjunctivitis in both adults and children. This Phase 3 clinical trial aims to show that fusidic acid 1% is superior to placebo in curing bacterial conjunctivitis and to further confirm its safety when applied topically to the eyes. Participants will be randomly assigned to one of two groups: one group will apply one drop of fusidic acid 1% in each eye twice daily for seven days, and the other group will use a placebo eye drop with the same schedule. The doses are ideally spaced about 12 hours apart, but the twice-daily application schedule is prioritized over exact timing. During the study, participants will be assessed for clinical cure and microbial eradication at Day 4 and Day 8 visits. Researchers will monitor safety and treatment effects through these evaluations and by tracking any adverse events. The total participation duration covers at least the seven days of treatment plus follow-up assessments, helping establish both effectiveness and safety profiles for the treatment.
CONDITIONS
Brief Title
Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of suspected bacterial conjunctivitis in at least one eye with purulent or mucopurulent discharge and a grade 2 on the modified Validated Bulbar Redness conjunctival redness scale
- No ocular treatment for conjunctivitis other than eyelid hygiene within 14 days before Visit 1
- Negative viral conjunctivitis test in both eyes
- Willing to stop using eye/eyelid cosmetics during study participation
- Willing to stop using contact lenses during study participation
- Able and willing to provide informed consent and comply with study requirements
- Not currently pregnant or breastfeeding; if sexually active, agrees to use approved contraception during the study
You will not qualify if you...
- Signs, symptoms, or diagnosis of fungal, protozoal, or viral eye infection within 30 days before Visit 1
- Bacterial conjunctivitis symptoms for more than 48 hours before Visit 1
- Need for non-study topical ocular medication or systemic medications disallowed by the protocol before Visit 1
- Abnormal ocular anatomy or eye disease/disorder specified as ineligible in the protocol
- Known intolerance, sensitivity, or allergy to study medications or their components
- Participation in another clinical trial within 30 days or use of another experimental drug within 90 days before Visit 1
- Family or household member enrolled in this study
- Any condition that may impact safety or study outcomes as judged by the investigator
- Employment or immediate family relation to an employee involved in the study conduct at the study site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants instill one drop of study medication per eye twice a day for 7 days to treat suspected bacterial conjunctivitis.
2 visits (Day 4 and Day 8, in-person)
Trial Site Locations
Total: 38 locations
1
Baxis Site 04
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Baxis Site 24
Huntington Beach, California, United States, 92647
Withdrawn
3
Baxis Site 19
La Jolla, California, United States, 92037
Actively Recruiting
4
Baxis Site 39
Long Beach, California, United States, 90813
Actively Recruiting
5
Baxis Site 31
Los Angeles, California, United States, 90020
Actively Recruiting
6
Baxis Site 38
Los Angeles, California, United States, 90048
Actively Recruiting
7
Baxis Site 20
Sherman Oaks, California, United States, 91423
Terminated
8
Baxis Site 34
Delray Beach, Florida, United States, 33484
Actively Recruiting
9
Baxis Site 22
Doral, Florida, United States, 33172
Terminated
10
Baxis Site 11
Lake Worth, Florida, United States, 33460
Actively Recruiting
11
Baxis Site 37
Largo, Florida, United States, 33773
Actively Recruiting
12
Baxis Site 27
Lutz, Florida, United States, 33549
Actively Recruiting
13
Baxis Site 01
Miami, Florida, United States, 33155
Actively Recruiting
14
Baxis Site 03
Miami, Florida, United States, 33176
Terminated
15
Baxis Site 13
Miami Beach, Florida, United States, 33140
Terminated
16
Baxis Site 28
Miami Lakes, Florida, United States, 33014
Actively Recruiting
17
Baxis Site 29
Palm Springs, Florida, United States, 33461
Actively Recruiting
18
Baxis Site 10
Tampa, Florida, United States, 33613
Actively Recruiting
19
Baxis Site 35
Union City, Georgia, United States, 30291
Actively Recruiting
20
Baxis Site 15
Idaho Falls, Idaho, United States, 83404
Terminated
21
Baxis Site 06
Orland Park, Illinois, United States, 60462
Actively Recruiting
22
Baxis Site 26
Columbia, Maryland, United States, 21045
Withdrawn
23
Baxis Site 21
North Las Vegas, Nevada, United States, 89030
Terminated
24
Baxis Site 23
Babylon, New York, United States, 11702
Withdrawn
25
Baxis Site 05
Mount Airy, North Carolina, United States, 27030
Terminated
26
Baxis Site 25
Tulsa, Oklahoma, United States, 74133
Withdrawn
27
Baxis Site 30
Gresham, Oregon, United States, 97030
Actively Recruiting
28
Baxis Site 09
Pittsburgh, Pennsylvania, United States, 15227
Withdrawn
29
Baxis Site 12
Charleston, South Carolina, United States, 29414
Actively Recruiting
30
Baxis Site 33
Greenville, South Carolina, United States, 29607
Actively Recruiting
31
Baxis Site 08
Edinburg, Texas, United States, 78539
Actively Recruiting
32
Baxis Site 02
Humble, Texas, United States, 77338
Terminated
33
Baxis Site 14
Kingwood, Texas, United States, 77345
Terminated
34
Baxis Site 36
Mission, Texas, United States, 78572
Actively Recruiting
35
Baxis Site 17
Layton, Utah, United States, 84041
Terminated
36
Baxis Site 18
Layton, Utah, United States, 84041
Terminated
37
Baxis Site 16
West Valley City, Utah, United States, 84120
Withdrawn
38
Baxis Site 32
Charlottesville, Virginia, United States, 22902
Actively Recruiting
Research Team
D
Director of Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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