Fluorometholone Study

Starting soon · Phase 2

Conditions studied: Keratitis Bacterial, Corneal Ulcer (Diagnosis)

In brief

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.

Key facts

Study ID

NCT07308938

Run by

Vishal Jhanji

People needed

174

Starts

2026-10-31

Expected to finish

2030-12-31

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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:
• Topical corticosteroids in the study eye, or
• Systemic corticosteroids during this ulcer episode.
• History of steroid-responsive glaucoma or uncontrolled intraocular pressure (IOP).

Where it is running

• UPMC Vision Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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