NCT07308938

Fluorometholone Study

Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Vishal Jhanji · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
DRUG	Adjunctive Topical Fluorometholone (FML) 0.1%	Adjunctive Topical Fluorometholone (FML) 0.1% will be used
DRUG	Standard Topical Antibiotic Therapy	Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician

Timeline

• Start date: 2026-05-31
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2025-12-30
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study