Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
174 participants
INTERVENTIONAL
2026-03-31
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Arm
Participant will be assigned Topical Antibiotics (fortified Tobramycin., fortified Cefazolin, Moxifloxacin)
Adjunctive Topical Fluorometholone (FML) 0.1%
Adjunctive Topical Fluorometholone (FML) 0.1% will be used with the standard topical antibiotic therapy (Tobramycin \[Tobrex\] and/or Cefazolin \[Ancef\]).
Control Arm
Participant will be assigned Topical Antibiotics (fortified Tobramycin, fortified Cefazolin, Moxifloxacin).
None-placebo
Patients will be treated with antibiotics
Interventions
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Adjunctive Topical Fluorometholone (FML) 0.1%
Adjunctive Topical Fluorometholone (FML) 0.1% will be used with the standard topical antibiotic therapy (Tobramycin \[Tobrex\] and/or Cefazolin \[Ancef\]).
None-placebo
Patients will be treated with antibiotics
Eligibility Criteria
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Inclusion Criteria
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
* 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).
18 Years
ALL
No
Sponsors
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University of Pittsburgh Medical Center
OTHER
Vishal Jhanji
OTHER
Responsible Party
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Vishal Jhanji
Professor of Ophthalmology
Principal Investigators
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Vishal Jhanji, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Vision Institute
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Rose Carla Aubourg, BA
Role: primary
Sarah Waters
Role: backup
Other Identifiers
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STUDY25110161
Identifier Type: -
Identifier Source: org_study_id