Fluorometholone Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adjunctive Topical Fluorometholone (FML) 0.1%, Standard Topical Antibiotic Therapy.
- Who it may be relevant to
- Registry conditions: Keratitis Bacterial, Corneal Ulcer (Diagnosis). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers
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.
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).
Interventions
- 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
Primary outcome measures
- Best Corrected Visual Acuity (BCVA) [Time frame: From enrollment to 3 months]
Secondary outcome measures (4)
- Visual Improvement [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) [Time frame: From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.]
- Complications [Time frame: From enrollment to Month 3.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UPMC Vision Institute — Pittsburgh
Identifiers
NCT: NCT07308938 · STUDY25110161