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Fluorometholone Study for Bacterial Corneal Ulcers

This study is testing if adding a medication called fluorometholone (FML) 0.1% eye drops to standard antibiotic treatment can improve vision for people with bacterial corneal ulcers. A corneal ulcer is an open sore on the clear front surface of your eye (cornea). You might be able to join if you are an adult (18 years or older) with a bacterial corneal ulcer that is mild, moderate, or severe. The main goal is to see if your best corrected vision improves after 3 months with the added FML. The current status of this study is unclear, but it plans to enroll 174 participants.

Study design
This is a prospective, randomized study comparing two groups of participants. It plans to enroll 174 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your vision will be measured from when you join the study until 3 months later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07308938

Fluorometholone Study

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Vishal Jhanji
~174 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Adjunctive Topical Fluorometholone (FML) 0.1%Standard Topical Antibiotic Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Corrected Visual Acuity (BCVA)
Measured over From enrollment to 3 months

Conditions

Keratitis Bacterial
Corneal Ulcer (Diagnosis)

Explore related trials

Bacterial keratitisCorneal Ulcer

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Vishal Jhanji, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Rose Carla Aubourg, BA
[email protected]
412-642-7888
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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. 4. Completed microbiologic work-up including ≥ 1 of:
Corneal culture, or
PCR testing. 5. Received ≥ 48-96 hours of empiric topical antibiotic therapy prior to randomization (fluoroquinolone monotherapy or fortified cefazolin/tobramycin based on standard of care). 6. Able and willing to provide informed consent and comply with study visits.

Exclusion

Herpes simplex keratitis.
Acanthamoeba keratitis.
Fungal keratitis (positive smear, culture or PCR). 2. Corneal perforation or imminent perforation at presentation. 3. Current use of:
Topical corticosteroids in the study eye, or
Systemic corticosteroids during this ulcer episode. 4. History of steroid-responsive glaucoma or uncontrolled intraocular pressure (IOP).

What this trial measures

  • Best Corrected Visual Acuity (BCVA)From enrollment to 3 months

    BCVA (logMAR) at 3 months post-randomization in the study eye.