At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 527 enrolled
Drug / intervention
Masked Placebo +1 moredrug
Likely dose
Valacyclovir 1000 mg orally once dailyAI-extracted
Key inclusion· 5
- ✓Age 18 years or older
- ✓Diagnosed with HZO in one eye with characteristic unilateral vesicular rash in V1 or V2 dermatome distribution
- ✓Medical record documentation of active dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, and/or iritis due to HZO within the preceding year
- ✓Chronic HZO participants must be on stable treatment regimen and off antivirals for at least 30 days before enrollment; recent onset HZO participants may be enrolled after completing acute antiviral treatment and off oral and topical antivirals by enrollment
Key exclusion· 7
- ✕History of immunocompromised status as defined by CDC contraindications for zoster vaccine, including active malignancy affecting bone marrow/lymphatic system, AIDS, CD4 ≤200 cells/ml, or high-dose corticosteroids (>prednisone 20 mg/day equivalent within 1 month)
- ✕Renal insufficiency: requires dialysis, history of renal transplant, or eGFR <45
- ✕Allergy or adverse reaction to valacyclovir or acyclovir
- ✕History of zoster vaccination within one month prior to enrollment (or one month after second dose of RZV/Shingrix)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus
In Brief
A Phase 4 clinical trial evaluating Masked Placebo and Masked Oral Valacyclovir for Herpes Zoster Ophthalmicus. Completed, enrolled 527 participants across 78 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster Ophthalmicus
CountriesCanada, United States
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartAug 2017
Primary CompletionDec 2023
Study CompletionJul 2024
TodayJul 2026
First PostedApr 28, 2017
Enrollment StartAug 23, 2017
Primary CompletionDec 31, 2023
Study CompletionJul 22, 2024
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 9.2 years ago
Interventions
Masked Placebodrug
Oral Placebo
Masked Oral Valacyclovirdrug
Oral Valacyclovir 1000 mg/day