NCT02382588|TerminatedPhase 2Results
Study Stopped
There were difficulties meeting the enrollment goal within stipulated time frames.
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There were difficulties meeting the enrollment goal within stipulated time frames.
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
Sponsor study identifier
interventional
8
1 country
1
Study Start
December 10, 2013
Actual (reported)Primary Completion
May 11, 2020
Actual (reported)Study Completion
May 11, 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 11, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2013
Actual (reported)March 3, 2015
Actual (reported)March 6, 2015
Actual (reported)May 11, 2020
Actual (reported)May 11, 2020
Actual (reported)July 8, 2021
Actual (reported)Corneal Ulcer Healing
Based on weekly slitlamp photographs
2 weeks
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.
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.
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.
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.
Northwestern University
Chicago, Illinois, 60611, United States
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.
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.
8 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2015
First Posted
March 6, 2015
Study Start
December 10, 2013
Actual (reported)Contact the study team to confirm eligibility.
Liesegang TJ. Corneal complications from herpes zoster ophthalmicus. Ophthalmology. 1985 Mar;92(3):316-24. doi: 10.1016/s0161-6420(85)34034-4.
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.
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.
Primary Completion
May 11, 2020
Actual (reported)Study Completion
May 11, 2020
Actual (reported)Last Updated
July 8, 2021
Results First Posted
July 8, 2021
Record last verified: 2021-06
Once the study is completed study results will be shared with the study subjects.
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Source: ClinicalTrials.gov.
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