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

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NYU Langone Health

Status and phase

Withdrawn
Phase 4

Conditions

Herpes Simplex Virus Keratitis

Treatments

Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops
Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily

Study type

Interventional

Funder types

Other

Identifiers

NCT03626376
17-01134

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
suppressive antiviral treatment
Treatment:
Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily
Study Arm
Active Comparator group
Description:
oral acyclovir or oral valacyclovir
Treatment:
Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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