Fluorometholone Study

Phase 2Not Yet RecruitingNCT07308938

Vishal Jhanji174 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

174

Conditions

Keratitis Bacterial Corneal Ulcer (Diagnosis)

Interventions

Adjunctive Topical Fluorometholone (FML) 0.1%DRUG

Adjunctive Topical Fluorometholone (FML) 0.1% will be used

Standard Topical Antibiotic TherapyDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

UPMC Vision Institute

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Best Corrected Visual Acuity (BCVA)

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

Time frame: From enrollment to 3 months

Secondary Outcomes

Visual Improvement

Change in BCVA from baseline to weeks 1 and 4, and 3 months.

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

Time to re-epithelialization

Time frame: From enrollment to 3 months

Intraocular Pressure (IOP)

IOP measurements at all follow-up visits.

Time frame: 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%.

Time frame: From enrollment to Month 3.

Central Contacts

Rose Carla Aubourg, BA

CONTACT

412-642-7888 aubourgrc@upmc.edu

Sarah Waters

CONTACT

412-642-7888 waterssa2@upmc.edu

Data from ClinicalTrials.gov

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