Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis

Phase 2

Terminated

• Conditions: Herpes Zoster Keratitis
• Interventions: Drug: gancyclovir gel; Drug: Hypromellose gel

• Registration Number: NCT02382588
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the treatment of herpes zoster keratitis. Half the patients will receive the study drug while the other half of the patients will receive the placebo

Detailed Description

Patients with herpes zoster keratitis will be enrolled in the study. All patients will receive oral anti-viral medication as a standard-of-care therapy. The patients will be randomized into two groups and given either the study drug or the placebo at the time of enrollment. The patients will come for weekly visits during which slit lamp photograph of the dendrite will be taken. At week 2, if the dendrite has not healed the drug will by unmasked and rescue therapy will be given. the patients will be examined at week 1, 2, and 3 or until resolution occurs.

Study Timeline

• Study Start: 2013-12-10
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Primary Completion: 2020-05-11
• Study Completion: 2020-05-11
• Results First Submitted: 2021-03-29
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Results First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• age 18 and above
• have not been on gancyclovir gel or any other form of topical antiviral therapy for the past month
• able and willing to attend subsequent follow-up visits

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Exclusion Criteria

• Associated retinitis
• patients who are allergic to gancyclovir
• patients who will require systemic or intra-vitreal gancyclovir therapy
• patients who are pregnant or breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gancyclovir gel	gancyclovir gel	0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.
hypromellose gel	Hypromellose gel	0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.

Primary Outcome Measures

Name	Time	Method
Corneal Ulcer Healing	2 weeks	Based on weekly slitlamp photographs

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States