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

NCT ID: NCT03626376

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2022-03-02

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.

Conditions

Herpes Simplex Virus Keratitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

suppressive antiviral treatment

Group Type: PLACEBO_COMPARATOR

oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily

Intervention Type: DRUG

Treatment used in standard of care

Study Arm

oral acyclovir or oral valacyclovir

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily

Treatment used in standard of care

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-01134

Identifier Type: -

Identifier Source: org_study_id