ClinicalTrials.gg
RecruitingNCT06911424Updated Mar 17, 2026

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

A Phase 3 interventional study of Fusidic Acid 1% and Placebo in Bacterial Conjunctivitis, sponsored by Baxis Pharmaceuticals, Inc.. Recruiting at 38 sites in United States. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by Baxis Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Sex
All
01

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.

02

Conditions studied

  • Bacterial Conjunctivitis

Keywords

  • Conjunctival Diseases
  • Eye Diseases
  • Eye Infections, Bacterial
  • Bacterial Infections
  • Infections
  • Eye Infections
  • Conjunctivitis, Bacterial
  • Conjunctivitis
03

In context

Conjunctivitis, Bacterial

40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.

This study's planned enrollment of 400 is above the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.

Browse Conjunctivitis, Bacterial studies →

Lead sponsor

This is the only study on the registry with Baxis Pharmaceuticals, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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 and comply with the study requirements.
  • Not be currently pregnant or breastfeeding. If sexually active, agree to use approved 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
400 participants (estimated)

Study 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

    Drug: Fusidic Acid 1%

  • 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

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Clinical Cure

    Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.

    Time frame: Visit 2 (Day 4)

Secondary outcomes

  1. Microbial Eradication

    Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.

    Time frame: Visit 2 (Day 4)

  2. Microbial Eradication

    Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.

    Time frame: Visit 3 (Day 8)

  3. Clinical Cure

    Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.

    Time frame: Visit 3 (Day 8)

07

Study locations

21 of 38 sites recruiting
  • Baxis Site 04
    Little Rock, Arkansas 72205, United States
    Recruiting
  • Baxis Site 24
    Huntington Beach, California 92647, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Baxis Site 19
    La Jolla, California 92037, United States
    Recruiting
  • Baxis Site 39
    Long Beach, California 90813, United States
    Recruiting
  • Baxis Site 31
    Los Angeles, California 90020, United States
    Recruiting
  • Baxis Site 38
    Los Angeles, California 90048, United States
    Recruiting
  • Baxis Site 20
    Sherman Oaks, California 91423, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 34
    Delray Beach, Florida 33484, United States
    Recruiting
  • Baxis Site 22
    Doral, Florida 33172, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 11
    Lake Worth, Florida 33460, United States
    Recruiting
  • Baxis Site 37
    Largo, Florida 33773, United States
    Recruiting
  • Baxis Site 27
    Lutz, Florida 33549, United States
    Recruiting
  • Baxis Site 01
    Miami, Florida 33155, United States
    Recruiting
  • Baxis Site 03
    Miami, Florida 33176, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 13
    Miami Beach, Florida 33140, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 28
    Miami Lakes, Florida 33014, United States
    Recruiting
  • Baxis Site 29
    Palm Springs, Florida 33461, United States
    Recruiting
  • Baxis Site 10
    Tampa, Florida 33613, United States
    Recruiting
  • Baxis Site 35
    Union City, Georgia 30291, United States
    Recruiting
  • Baxis Site 15
    Idaho Falls, Idaho 83404, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 06
    Orland Park, Illinois 60462, United States
    Recruiting
  • Baxis Site 26
    Columbia, Maryland 21045, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Baxis Site 21
    North Las Vegas, Nevada 89030, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 23
    Babylon, New York 11702, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Baxis Site 05
    Mount Airy, North Carolina 27030, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 25
    Tulsa, Oklahoma 74133, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Baxis Site 30
    Gresham, Oregon 97030, United States
    Recruiting
  • Baxis Site 09
    Pittsburgh, Pennsylvania 15227, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Baxis Site 12
    Charleston, South Carolina 29414, United States
    Recruiting
  • Baxis Site 33
    Greenville, South Carolina 29607, United States
    Recruiting
  • Baxis Site 08
    Edinburg, Texas 78539, United States
    Recruiting
  • Baxis Site 02
    Humble, Texas 77338, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 14
    Kingwood, Texas 77345, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 36
    Mission, Texas 78572, United States
    Recruiting
  • Baxis Site 17
    Layton, Utah 84041, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 18
    Layton, Utah 84041, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Baxis Site 16
    West Valley City, Utah 84120, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Baxis Site 32
    Charlottesville, Virginia 22902, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06911424
Lead sponsor
Baxis Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Apr 4, 2025
Start date
Mar 21, 2025
Primary completion
Mar 16, 2026 (estimated)
Completion
Mar 23, 2026 (estimated)
Last update
Mar 17, 2026

Study contacts

Director of Clinical Operations
Contact
info@baxis.com
4349808100

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Fusidic Acid

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