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

Herpes Zoster Keratitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02382588
• Other study ID #: 4321
• Status: Terminated
• Phase: Phase 2
• Start date: December 10, 2013
• Est. completion date: May 11, 2020

Study information

• Verified date: June 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 11, 2020
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Herpes Zoster Keratitis
• Herpes Zoster Ophthalmicus
• Keratitis

Intervention

Drug:
• 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
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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (5)

Liesegang TJ. Corneal complications from herpes zoster ophthalmicus. Ophthalmology. 1985 Mar;92(3):316-24. — View 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. Review. — View 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. — View 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. — View Citation

Villarreal EC. Current and potential therapies for the treatment of herpes-virus infections. Prog Drug Res. 2003;60:263-307. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Ulcer Healing	Based on weekly slitlamp photographs	2 weeks