This is a prospective, randomized clinical trial looking to determine the role of prophylactic treatment with topical corticosteroids in preventing recurrences in patients with a history of infectious epithelial keratitis, stromal keratitis,endotheliitis, or iridocyclitis. Patients will be enrolled to one of two treatment arms: Control arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg daily or Study arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Treatment used in standard of care
Topical steroid medications to be used in this study include Prednisolone acetate 1.0% or Prednisolone sodium phosphate 1%. The choice of formulation will be dependent on physician preference and medication availability. Formulations of other potencies such as Difluprednate emulsion will not be used in this study. Patients in the study arm will be started on topical corticosteroid 1 drop once a day in the affected eye.
New York University School of Medicine
New York, New York, United States
Measure of time to first recurrence
Kaplan-Meier curves will be plotted by treatment arm (overall and by site) and 95% confidence intervals for the difference between the time to first recurrences will be estimated. Results will also be plotted by site to provide descriptive summaries of the results.
Time frame: 24 Months
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