Fluorometholone Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Keratitis Bacterial; Corneal Ulcer (Diagnosis)
• Intervention / Treatment: Drug: Adjunctive Topical Fluorometholone (FML) 0.1%; Drug: Standard Topical Antibiotic Therapy

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 Type: Interventional
• Enrollment (Estimated): 174
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rose Carla Aubourg, BA; Phone Number: 412-642-7888; Email: aubourgrc@upmc.edu
• Study Contact Backup: Name: Sarah Waters; Phone Number: 412-642-7888; Email: waterssa2@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • UPMC Vision Institute
      • Principal Investigator: Vishal Jhanji, MD
      • Contact: Rose Carla Aubourg, BA; Phone Number: 412-642-7888; Email: aubourgrc@upmc.edu
      • Contact: Sarah Waters; Phone Number: 412-642-7888; Email: waterssa2@upmc.edu
      • Sub-Investigator: Alex Mammen, MD
      • Sub-Investigator: Sabrina Mukhtar, MD
      • Sub-Investigator: Prakash Gaurav, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged ≥ 18 years.
2. Clinical diagnosis of a bacterial corneal ulcer based on slit-lamp examination.

3. 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.

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 Criteria:

1. Clinical or laboratory evidence of:

   • 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Standard Topical Antibiotic Therapy + Fluorometholone	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
Active Comparator: Control Arm; Standard Topical Antibiotic Therapy Alone	Drug: Standard Topical Antibiotic Therapy; Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity (BCVA)	BCVA (logMAR) at 3 months post-randomization in the study eye.	From enrollment to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Improvement	Change in BCVA from baseline to weeks 1 and 4, and 3 months.	From enrollment (Day 1) to Week 1, Month 1, Month 3.
Time to re-epithelialization	Time to re-epithelialization	From enrollment to 3 months
Intraocular Pressure (IOP)	IOP measurements at all follow-up visits.	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%.	From enrollment to Month 3.

Collaborators and Investigators

• Sponsor: Vishal Jhanji
• Collaborators: University of Pittsburgh Medical Center
• Investigators: Principal Investigator: Vishal Jhanji, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 27, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Eye Diseases; Corneal Diseases; Keratitis; Eye Infections; Pathological Conditions, Signs and Symptoms; Disease; Corneal Ulcer; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienediols; Fluorometholone
• Other Study ID Numbers: STUDY25110161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data would be made available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No