Back to resultsTopical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
Primary Purpose
Herpes Simplex Virus Keratitis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily
oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Simplex Virus Keratitis
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Study Arm
Arm Description
suppressive antiviral treatment
oral acyclovir or oral valacyclovir
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03626376
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to enroll participants
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
March 2, 2021 (Anticipated)
Study Completion Date
March 2, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex Virus Keratitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
suppressive antiviral treatment
Arm Title
Study Arm
Arm Type
Active Comparator
Arm Description
oral acyclovir or oral valacyclovir
Intervention Type
Drug
Intervention Name(s)
oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily
Intervention Description
Treatment used in standard of care
Intervention Type
Drug
Intervention Name(s)
oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of time to first recurrence
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
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