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

Northwestern University

Status and phase: Terminated; Phase 2

Conditions: Herpes Zoster Keratitis

Treatments: Drug: Hypromellose gel; Drug: gancyclovir gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02382588

4321

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups, including a placebo group

Gancyclovir gel

Experimental group

Description:

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.

Treatment:

Drug: gancyclovir gel

hypromellose gel

Placebo Comparator group

Description:

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.

Treatment:

Drug: Hypromellose gel