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

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Double-masked, Placebo Controlled Comparison of Topical 0.15% Gancyclovir Gel (Zirgan) Versus 0.3% Hypromellose Gel (Genteal Gel; Placebo) for the Treatment of Herpes Zoster Keratitis

Conditions
-----------------
Herpes Zoster Keratitis

Intervention / Treatment
-----------------
* Drug: gancyclovir gel
* Drug: Hypromellose gel


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gancyclovir gel<br>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. | Drug: gancyclovir gel<br>* 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.<br>* Other names: zirgan;|
| Placebo Comparator: hypromellose gel<br>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. | Drug: Hypromellose gel<br>* 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.<br>* Other names: genteal gel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Ulcer Healing | Based on weekly slitlamp photographs | 2 weeks |