Keratitis BacterialPhase 2NCT07308938
Fluorometholone Study
A Phase 2 study testing Adjunctive Topical Fluorometholone (FML) 0.1% and Standard Topical Antibiotic Therapy in people with Keratitis Bacterial and Corneal Ulcer (Diagnosis), run by Vishal Jhanji at 1 site in United States.
Trial summary
The investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratitis Bacterial, Corneal Ulcer (Diagnosis)
- What is being tested?
- Adjunctive Topical Fluorometholone (FML) 0.1% and Standard Topical Antibiotic Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 31 Dec 2030
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 18 years.
- Clinical diagnosis of a bacterial corneal ulcer based on slit-lamp examination.
- Ulcer severity classified as:
- Mild: Diameter ≤ 3 mm AND stromal depth ≤ 1/3 thickness.
- Moderate: Diameter >3-6 mm and/or stromal depth > 1/3-2/3.
- Severe: Diameter >6 mm and/or stromal depth >2/3.
Show all 11Show fewer
- Completed microbiologic work-up including ≥ 1 of:
- Corneal culture, or
- PCR testing.
- Received ≥ 48-96 hours of empiric topical antibiotic therapy prior to randomization (fluoroquinolone monotherapy or fortified cefazolin/tobramycin based on standard of care).
- Able and willing to provide informed consent and comply with study visits.
Who cannot join
- Clinical or laboratory evidence of:
- Herpes simplex keratitis.
- Acanthamoeba keratitis.
- Fungal keratitis (positive smear, culture or PCR).
- Corneal perforation or imminent perforation at presentation.
- Current use of:
Show all 9Show fewer
- Topical corticosteroids in the study eye, or
- Systemic corticosteroids during this ulcer episode.
- History of steroid-responsive glaucoma or uncontrolled intraocular pressure (IOP).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UPMC Vision Institute
Pittsburgh, Pennsylvania, 15219
Rose Carla Aubourg, BA, 412-642-7888, aubourgrc@upmc.edu
Sarah Waters, 412-642-7888, waterssa2@upmc.edu
About this study
Official title: Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers
The investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone.
Read the detailed description
In this prospective, randomized, parallel-group clinical cohort study, the investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone. The primary objective is to compare the mean 3-month BCVA (logMAR) between the intervention arm (standard topical antibiotic therapy + FML 0.1%) and a control arm (standard topical antibiotic therapy alone).
- Conditions
- Keratitis Bacterial, Corneal Ulcer (Diagnosis)
- Being tested
- Adjunctive Topical Fluorometholone (FML) 0.1%, Standard Topical Antibiotic Therapy
- Medical subject headings
- Corneal Ulcer, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive Topical Fluorometholone (FML) 0.1%Drug
Adjunctive Topical Fluorometholone (FML) 0.1% will be used
Standard Topical Antibiotic TherapyDrug
Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Standard Topical Antibiotic Therapy + Fluorometholone Receives: Drug: Adjunctive Topical Fluorometholone (FML) 0.1%; Drug: Standard Topical Antibiotic Therapy |
| Control Arm | Active comparator | Standard Topical Antibiotic Therapy Alone Receives: Drug: Standard Topical Antibiotic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA)
BCVA (logMAR) at 3 months post-randomization in the study eye.
Measured: From enrollment to 3 months
Secondary outcomes (4)
Visual Improvement
Change in BCVA from baseline to weeks 1 and 4, and 3 months.
Measured: From enrollment (Day 1) to Week 1, Month 1, Month 3.
Time to re-epithelialization
Time to re-epithelialization
Measured: From enrollment to 3 months
Intraocular Pressure (IOP)
IOP measurements at all follow-up visits.
Measured: From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.
Complications
Progressive thinning or perforation; hypopyon development or increase; endophthalmitis; fibrin formation; or worsening infiltrate size or depth ≥50%.
Measured: From enrollment to Month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start31 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratitis BacterialStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, parallel-group clinical cohort study.
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vishal Jhanji
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Sponsor-investigator, Vishal Jhanji, University of Pittsburgh
- Investigators
- Vishal Jhanji, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308938
- Sponsor's protocol ID
- STUDY25110161
- Status last verified
- Apr 2026
- First submitted
- 26 Dec 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The data would be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers
- ClinicalTrials.gov ID
- NCT07308938
- Acronym / sponsor ID
- STUDY25110161
- Conditions
- Keratitis Bacterial, Corneal Ulcer (Diagnosis)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Vishal JhanjiUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Dec 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 investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone.
Detailed description
In this prospective, randomized, parallel-group clinical cohort study, the investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone. The primary objective is to compare the mean 3-month BCVA (logMAR) between the intervention arm (standard topical antibiotic therapy + FML 0.1%) and a control arm (standard topical antibiotic therapy alone).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized, parallel-group clinical cohort study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Adjunctive Topical Fluorometholone (FML) 0.1%, Drug: Standard Topical Antibiotic TherapyStandard Topical Antibiotic Therapy + Fluorometholone |
| Control Arm | Active comparator | Drug: Standard Topical Antibiotic TherapyStandard Topical Antibiotic Therapy Alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults aged ≥ 18 years.
- Clinical diagnosis of a bacterial corneal ulcer based on slit-lamp examination.
- Ulcer severity classified as:
- Completed microbiologic work-up including ≥ 1 of:
- Received ≥ 48-96 hours of empiric topical antibiotic therapy prior to randomization (fluoroquinolone monotherapy or fortified cefazolin/tobramycin based on standard of care).
Key exclusion criteria (9 listed)
- Clinical or laboratory evidence of:
- Corneal perforation or imminent perforation at presentation.
- Current use of:
- History of steroid-responsive glaucoma or uncontrolled intraocular pressure (IOP).
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 |
|---|---|---|
| Adjunctive Topical Fluorometholone (FML) 0.1%Adjunctive Topical Fluorometholone (FML) 0.1% will be used | Drug | Intervention Arm |
| Standard Topical Antibiotic TherapyPatients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician | Drug | Control Arm, Intervention Arm |
Primary outcome
Best Corrected Visual Acuity (BCVA)
Time frame: From enrollment to 3 months
BCVA (logMAR) at 3 months post-randomization in the study eye.
4 secondary outcomes
Visual Improvement
Time frame: From enrollment (Day 1) to Week 1, Month 1, Month 3.
Time to re-epithelialization
Time frame: From enrollment to 3 months
Intraocular Pressure (IOP)
Time frame: From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.
Complications
Time frame: From enrollment to Month 3.
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 10 Jun 2026.
- Individual participant dataSharing planned: No. The data would be made available upon reasonable request.
Related trials for Keratitis Bacterial
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Active, not recruitingPhase 3
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Bacterial Keratitis
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Not yet recruiting
Effect of Sodium Chloride 5% Solution as an Adjuvant Treatment With Antimicrobial Therapy in the Treatment of Bacterial Infectious Keratitis
Infectious Keratitis, Adjuvant Treatment Bacterial Infectious Keratitis
RecruitingPhase 1
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
Keratoconus, Unstable, Bacterial Keratitis
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.
Vishal Jhanji, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adjunctive Topical Fluorometholone (FML) 0.1% and Standard Topical Antibiotic Therapy in people with Keratitis Bacterial and Corneal Ulcer (Diagnosis), run by Vishal Jhanji at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rose Carla Aubourg, BA (412-642-7888, aubourgrc@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (BCVA) (time frame: From enrollment to 3 months). 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 10 Jun 2026.