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NCT03134196 · ClinicalTrials.gov registry record · Phase 4

Zoster Eye Disease Study

A Phase 4 study of Herpes Zoster Ophthalmicus, sponsored by NYU Langone Health.

Completed
Registry status
Phase 4
Development phase
527
Enrollment target
20
Study locations

NCT03134196: Completed Phase 4 study of Herpes Zoster Ophthalmicus, sponsored by NYU Langone Health.

NCT03134196 is a Phase 4 study of Herpes Zoster Ophthalmicus that has completed, run by NYU Langone Health. The registered enrollment target is 527 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03134196, a Phase 4 study of Herpes Zoster Ophthalmicus, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 4
Development phase
527 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

The number of participants with the first confirmed endpoint (new or worsening SK, EK, IR, DEK or SKU associated with pre-specified definitions of these disease manifestations and associated treatment requirements within 12 months in study participants assigned to valacyclovir compared to placebo. Diagnostic criteria were defined using the classification for SK, EK, SKU, and DEK caused by Herpes Simplex Virus (HSV) and standardization of uveitis nomenclature (SUN) for IR. A substantial increase

Conditions Studied

Interventions

  • DRUG Masked Placebo
  • DRUG Masked Oral Valacyclovir

Study Locations (20)

California

  • Scripps Clinic - La Jolla
  • Loma Linda University Eye Institute - Loma Linda
  • Jules Stein Eye Clinic - UCLA - Los Angeles
  • Byers Eye Institute at Stanford University - Palo Alto
  • UCSF- Francis I. Proctor Foundation - San Francisco
  • Pacific Eye Surgeons, Inc. - San Luis Obispo

Florida

  • Delray Eye Associates, PA - Delray Beach
  • University of Florida - Gainesville
  • Florida Eye Specialists - Jacksonville
  • University of Miami - Bascom Palmer Eye Institute - Miami

Colorado

  • University of Colorado - Aurora
  • Colorado Cornea Consultants P.C. - Littleton

Illinois

  • University of Illinois - Chicago
  • NorthShore University Health System - Glenview

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • Mayo Clinic - Arizona - Scottsdale

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

District of Columbia

  • Medstar Georgetown University Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 527 participants
Start Date 2017-08-23
Est. Completion 2024-07-22
Phase Phase 4
NYU Langone Health

1,164 total trials

What the finished NCT03134196 record still lists

NCT03134196 is an interventional study that assigns participants to a tested intervention. The registered 527 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.

The record links to 1 condition, with Herpes Zoster Ophthalmicus appearing as the primary indexed condition, and to 2 interventions - of which Masked Placebo is the first listed.

NCT03134196 names 20 study sites across 10 states, led by California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT03134196 about?

NCT03134196 is a clinical study titled "Zoster Eye Disease Study". 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 Ophthal...

What is the current status of trial NCT03134196?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 527 participants. The study started on 2017-08-23. Estimated completion is 2024-07-22.

What conditions does trial NCT03134196 study?

This clinical trial studies the following conditions: Herpes Zoster Ophthalmicus.

What interventions are being tested in trial NCT03134196?

The interventions under investigation include: Masked Placebo (DRUG), Masked Oral Valacyclovir (DRUG).

Who is sponsoring clinical trial NCT03134196?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03134196 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03134196's enrollment target sits among peer trials

527 157th of 2000 higher than 1,844 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03134196, the US trial registry maintained by the National Library of Medicine. NCT03134196 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.