Not Yet RecruitingPhase 2

Fluorometholone Study

United States174 participantsStarted 2026-05-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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).
✓. Able and willing to provide informed consent and comply with study visits.

Exclusion criteria

✕. 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).

What they're measuring

Best Corrected Visual Acuity (BCVA)

Timeframe: From enrollment to 3 months

Trial details

NCT IDNCT07308938

SponsorVishal Jhanji

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Rose Carla Aubourg, BA

412-642-7888 aubourgrc@upmc.edu

View on ClinicalTrials.gov More Keratitis Bacterial trials