Fluorometholone Study

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Vishal Jhanji
Study ID
NCT07308938
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Corneal Ulcer (Diagnosis)
  • Keratitis Bacterial

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adjunctive Topical Fluorometholone (FML) 0.1% — DRUG
    Adjunctive Topical Fluorometholone (FML) 0.1% will be used
  • Standard Topical Antibiotic Therapy — DRUG
    Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician

Study Details

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.

Key Dates

Start date
Oct 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Arm
    Standard Topical Antibiotic Therapy + Fluorometholone
  • Active Comparator: Control Arm
    Standard Topical Antibiotic Therapy Alone

Primary Outcome Measure

Best Corrected Visual Acuity (BCVA) [ Time Frame: From enrollment to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Vision InstitutePittsburghPennsylvania15219
Rose Carla Aubourg, BA
[email protected]
412-642-7888
Sarah Waters
[email protected]
412-642-7888
Vishal Jhanji, MD (PRINCIPAL_INVESTIGATOR)
Alex Mammen, MD (SUB_INVESTIGATOR)
Sabrina Mukhtar, MD (SUB_INVESTIGATOR)
Prakash Gaurav, MD (SUB_INVESTIGATOR)

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UPMC Vision Institute· Pittsburgh, PA