Fluorometholone Study

NCT07308938 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY25110161
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Keratitis Bacterial; Corneal Ulcer (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity (BCVA)

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

  From enrollment to 3 months

Secondary Outcomes (4)

• Visual Improvement

  From enrollment (Day 1) to Week 1, Month 1, Month 3.

• Time to re-epithelialization

  From enrollment to 3 months

• Intraocular Pressure (IOP)

  From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.

• Complications

  From enrollment to Month 3.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Standard Topical Antibiotic Therapy + Fluorometholone

Drug: Adjunctive Topical Fluorometholone (FML) 0.1%; Drug: Standard Topical Antibiotic Therapy

Control Arm

ACTIVE COMPARATOR

Standard Topical Antibiotic Therapy Alone

Drug: Standard Topical Antibiotic Therapy

Interventions

Standard Topical Antibiotic Therapy DRUG

Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician

Control Arm; Intervention Arm

Adjunctive Topical Fluorometholone (FML) 0.1% DRUG

Adjunctive Topical Fluorometholone (FML) 0.1% will be used

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Vishal Jhanji: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

UPMC Vision Institute

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Corneal Ulcer; Disease

Interventions

Fluorometholone

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Vishal Jhanji, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rose Carla Aubourg, BA

CONTACT

412-642-7888; aubourgrc@upmc.edu

Sarah Waters

CONTACT

412-642-7888; waterssa2@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: A prospective, randomized, parallel-group clinical cohort study.

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: December 30, 2025
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)