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Zoster Eye Disease Study

NCT03134196 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2025-03-07

Study results available
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Summary

This is a multi-center, randomized, double-masked, placebo-controlled clinical trial of suppressive valacyclovir for one year in immunocompetent study participants with an episode of dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to Herpes Zoster Ophthalmicus (HZO) in the year prior to enrollment.

Conditions

  • Herpes Zoster Ophthalmicus

Interventions

DRUG

Masked Placebo

Oral Placebo

DRUG

Masked Oral Valacyclovir

Oral Valacyclovir 1000 mg/day

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Elisabeth Cohen, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2023-12-31
Completion
2024-07-22
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03134196 on ClinicalTrials.gov