Clinical trial NCT03626376: Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
Official title: A Randomized Trial of Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Herpes Simplex Virus Keratitis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject capable of giving informed consent and if not, an acceptable surrogate capable of giving informed consent on behalf of the subject.
* Diagnosed with a history of herpetic eye disease
* Three or more episodes of HSV keratitis based on medical record documentation of episodes with infectious epithelial keratitis, immune stromal keratitis with or without epithelial ulceration, endothelitis, or iridocyclitis.
* Prior history of HSV keratitis based on medical record documentation of episode of infectious epithelial keratitis, immune stromal keratitis with or without epithelial ulceration, endothelitis, or iridocyclitis and corneal scarring in the central 4mm zone.

Exclusion Criteria:

* Persons who are pregnant or nursing or intend to become pregnant or nurse in the next one year.
* Allergy to acyclovir, fluoromethalone, loteprednol, prednisolone acetate, prednisolone sodium phosphate, or any components of the formulations.
* Persons who are incarcerated.
* Unable to give informed consent or have an acceptable surrogate capable of giving informed consent on behalf of the subject.
* Persons with systemic medical problems who do not agree to have continued medical follow-up.
* History of topical corticosteroids to the eyelids or ocular surface of the involved eye within the prior 30 days prior to enrollment.
* Patients with 3 or more episodes of uveitis in the past 12 months.
* History of keratoplasy or keratorefractive surgery of the involved eye.
* History of open or closed angle glaucoma or ocular hypertension on gtts.
* History of systemic steroid use within the prior 30 days.
* Unable to comply with the study protocol or in the opinion of the investigator would not be a candidate for participation.
* Persons who are unable to instill gtts despite training/caregiver.

Primary outcomes:
measure: Measure of time to first recurrence
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
References: