Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis

Conditions

• Herpes Simplex Virus Keratitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily — DRUG
  Treatment used in standard of care
• oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops — DRUG
  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.

Study Details

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.

Key Dates

Start date

Dec 10, 2019

Status verified

Dec 2021

Primary completion

Mar 2, 2021

Completion

Mar 2, 2022

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: Control
  suppressive antiviral treatment
• Active Comparator: Study Arm
  oral acyclovir or oral valacyclovir

Primary Outcome Measure

Measure of time to first recurrence [ Time Frame: 24 Months ]

Locations (1)

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