Bacterial ConjunctivitisPhase 3NCT06911424
Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
A Phase 3 study testing Fusidic Acid 1% in people with Bacterial Conjunctivitis, run by Baxis Pharmaceuticals, Inc. at 38 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- Fusidic Acid 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 38 sitesUnited States
- Study dates
- 21 Mar 2025to 23 Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 locations and contacts
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
38 sites in 1 country
United States38 sites, 21 recruiting
- Withdrawn
Baxis Site 23
Babylon, New York, 11702
- Recruiting
Baxis Site 12
Charleston, South Carolina, 29414
info@baxis.com
- Recruiting
Baxis Site 32
Charlottesville, Virginia, 22902
info@baxis.com
- Withdrawn
Baxis Site 26
Columbia, Maryland, 21045
- Recruiting
Baxis Site 34
Delray Beach, Florida, 33484
info@baxis.com
- Terminated
Baxis Site 22
Doral, Florida, 33172
- Recruiting
Baxis Site 08
Edinburg, Texas, 78539
info@baxis.com
- Recruiting
Baxis Site 33
Greenville, South Carolina, 29607
info@baxis.com
- Recruiting
Baxis Site 30
Gresham, Oregon, 97030
info@baxis.com
- Terminated
Baxis Site 02
Humble, Texas, 77338
- Withdrawn
Baxis Site 24
Huntington Beach, California, 92647
- Terminated
Baxis Site 15
Idaho Falls, Idaho, 83404
- Terminated
Baxis Site 14
Kingwood, Texas, 77345
- Recruiting
Baxis Site 19
La Jolla, California, 92037
info@baxis.com
- Recruiting
Baxis Site 11
Lake Worth, Florida, 33460
info@baxis.com
- Recruiting
Baxis Site 37
Largo, Florida, 33773
info@baxis.com
- Terminated
Baxis Site 17
Layton, Utah, 84041
- Terminated
Baxis Site 18
Layton, Utah, 84041
- Recruiting
Baxis Site 04
Little Rock, Arkansas, 72205
info@baxis.com
- Recruiting
Baxis Site 39
Long Beach, California, 90813
info@baxis.com
- Recruiting
Baxis Site 31
Los Angeles, California, 90020
info@baxis.com
- Recruiting
Baxis Site 38
Los Angeles, California, 90048
info@baxis.com
- Recruiting
Baxis Site 27
Lutz, Florida, 33549
info@baxis.com
- Recruiting
Baxis Site 01
Miami, Florida, 33155
info@baxis.com
- Terminated
Baxis Site 03
Miami, Florida, 33176
- Terminated
Baxis Site 13
Miami Beach, Florida, 33140
- Recruiting
Baxis Site 28
Miami Lakes, Florida, 33014
info@baxis.com
- Recruiting
Baxis Site 36
Mission, Texas, 78572
info@baxis.com
- Terminated
Baxis Site 05
Mount Airy, North Carolina, 27030
- Terminated
Baxis Site 21
North Las Vegas, Nevada, 89030
- Recruiting
Baxis Site 06
Orland Park, Illinois, 60462
info@baxis.com
- Recruiting
Baxis Site 29
Palm Springs, Florida, 33461
info@baxis.com
- Withdrawn
Baxis Site 09
Pittsburgh, Pennsylvania, 15227
- Terminated
Baxis Site 20
Sherman Oaks, California, 91423
- Recruiting
Baxis Site 10
Tampa, Florida, 33613
info@baxis.com
- Withdrawn
Baxis Site 25
Tulsa, Oklahoma, 74133
- Recruiting
Baxis Site 35
Union City, Georgia, 30291
info@baxis.com
- Withdrawn
Baxis Site 16
West Valley City, Utah, 84120
About this study
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
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.
- Conditions
- Bacterial Conjunctivitis
- Being tested
- Fusidic Acid 1%, Placebo
- Keywords
- Conjunctival Diseases, Eye Diseases, Eye Infections, Bacterial, Bacterial Infections, Infections, Eye Infections, Conjunctivitis, Bacterial, Conjunctivitis
- Medical subject headings
- Conjunctivitis, Bacterial, Conjunctival Diseases, Eye Diseases, Eye Infections, Bacterial, Bacterial Infections, Infections, Eye Infections, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fusidic Acid 1%Drug
Fusidic acid 1%
PlaceboDrug
Placebo ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Fusidic Acid 1% | Experimental | 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 Receives: Drug: Fusidic Acid 1% |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure
Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
Measured: Visit 2 (Day 4)
Secondary outcomes (3)
Microbial Eradication
Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.
Measured: Visit 2 (Day 4)
Microbial Eradication
Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication.
Measured: Visit 3 (Day 8)
Clinical Cure
Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
Measured: Visit 3 (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start21 Mar 2025
- Primary completion16 Mar 2026 (estimated)
- Study completion23 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911424
- Sponsor's protocol ID
- BXP-301
- Status last verified
- Dec 2025
- First submitted
- 19 Mar 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06911424
- Acronym / sponsor ID
- BXP-301
- Conditions
- Bacterial Conjunctivitis
- Keywords
- Conjunctival Diseases, Eye Diseases, Eye Infections, Bacterial, Bacterial Infections, Infections, Eye Infections, Conjunctivitis, Bacterial, Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Baxis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 16 Mar 2026 (estimated)
- Study completion
- 23 Mar 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fusidic Acid 1% | Experimental | Drug: 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 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fusidic Acid 1%Fusidic acid 1% | Drug | Fusidic Acid 1% |
| PlaceboPlacebo ophthalmic solution | Drug | Placebo |
Primary outcome
Clinical Cure
Time frame: Visit 2 (Day 4)
Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
3 secondary outcomes
Microbial Eradication
Time frame: Visit 2 (Day 4)
Microbial Eradication
Time frame: Visit 3 (Day 8)
Clinical Cure
Time frame: Visit 3 (Day 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fusidic Acid 1% in people with Bacterial Conjunctivitis, run by Baxis Pharmaceuticals, Inc. at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director of Clinical Operations (4349808100, info@baxis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure (time frame: Visit 2 (Day 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.