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

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ClinicalTrials.gov Identifier: NCT03626376
Recruitment Status : Not yet recruiting
First Posted : August 13, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Virus Keratitis Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
suppressive antiviral treatment
Drug: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily
Treatment used in standard of care

Active Comparator: Study Arm
oral acyclovir or oral valacyclovir
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.




Primary Outcome Measures :
  1. Measure of time to first recurrence [ Time Frame: 24 Months ]
    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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626376


Contacts
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Contact: Stacy Mach 929 455 5539 stacy.mach@nyumc.org

Locations
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United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Stacy Mach    929-455-5539    Stacy.Mach@nyumc.org   
Principal Investigator: Leela Raju, MD         
Sponsors and Collaborators
NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03626376     History of Changes
Other Study ID Numbers: 17-01134
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Herpes Simplex
Keratitis
Recurrence
Virus Diseases
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Corneal Diseases
Eye Diseases
Antiviral Agents
Valacyclovir
Acyclovir
Anti-Infective Agents