Fluorometholone Study

Vishal Jhanji

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Keratitis Bacterial; Corneal Ulcer (Diagnosis)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07308938

STUDY25110161

Details and patient eligibility

About

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.

Full 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).

Enrollment: 174 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

174 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Standard Topical Antibiotic Therapy + Fluorometholone

Treatment:

Drug: Adjunctive Topical Fluorometholone (FML) 0.1%

Drug: Standard Topical Antibiotic Therapy

Control Arm

Active Comparator group

Description:

Standard Topical Antibiotic Therapy Alone

Treatment:

Drug: Standard Topical Antibiotic Therapy