Clinical trial NCT02382588: Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Herpes Zoster Keratitis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2015-03-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Corneal Ulcer Healing
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: Liesegang TJ. Herpes zoster ophthalmicus natural history, risk factors, clinical presentation, and morbidity. Ophthalmology. 2008 Feb;115(2 Suppl):S3-12. doi: 10.1016/j.ophtha.2007.10.009.
citation: Ostler HB, Thygeson P. The ocular manifestations of herpes zoster, varicella, infectious mononucleosis, and cytomegalovirus disease. Surv Ophthalmol. 1976 Sep-Oct;21(2):148-59. doi: 10.1016/0039-6257(76)90092-8.
citation: Liesegang TJ. Corneal complications from herpes zoster ophthalmicus. Ophthalmology. 1985 Mar;92(3):316-24. doi: 10.1016/s0161-6420(85)34034-4.
citation: Trousdale MD, Nesburn AB, Willey DE, Taaid H. Efficacy of BW759 (9-[[2-hydroxy-1(hydroxymethyl)ethoxy]methyl]guanine) against herpes simplex virus type 1 keratitis in rabbits. Curr Eye Res. 1984 Aug;3(8):1007-15. doi: 10.3109/02713688409011747.
citation: Villarreal EC. Current and potential therapies for the treatment of herpes-virus infections. Prog Drug Res. 2003;60:263-307. doi: 10.1007/978-3-0348-8012-1_8.