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

NCT ID: NCT02382588

Last Updated: 2021-07-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-10

Study Completion Date

2020-05-11

Brief Summary

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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

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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.

Conditions

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Herpes Zoster Keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

gancyclovir gel

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Hypromellose gel

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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zirgan genteal gel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Robert Feder

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18243930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 185734 (View on PubMed)

Liesegang TJ. Corneal complications from herpes zoster ophthalmicus. Ophthalmology. 1985 Mar;92(3):316-24. doi: 10.1016/s0161-6420(85)34034-4.

Reference Type BACKGROUND
PMID: 3873048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6333319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12790345 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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4321

Identifier Type: -

Identifier Source: org_study_id

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