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

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ClinicalTrials.gov Identifier: NCT02382588
Recruitment Status : Recruiting
First Posted : March 6, 2015
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Robert Feder, Northwestern University

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

Condition or disease Intervention/treatment Phase
Herpes Zoster Keratitis Drug: gancyclovir gel Drug: Hypromellose gel Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: zirgan

Placebo Comparator: 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.
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.
Other Name: genteal gel




Primary Outcome Measures :
  1. Healing based on weekly slitlamp photographs [ Time Frame: 2 weeks ]
    Based on weekly slitlamp photographs



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382588


Contacts
Contact: Robert S Feder, MD, MBA 312-695-8150 r-feder@northwestern.edu
Contact: Nicole Seddon 312-695-0252 nreinhol@nm.org

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert S Feder, MD, MBA    312-695-8150    r-feder@northwestrn.edu   
Contact: Nicole Seddon    312-695-0252    nreinhol@nm.org   
Sponsors and Collaborators
Northwestern University
Bausch & Lomb Incorporated

Publications:
Responsible Party: Robert Feder, Professor of Ophthalmology, Northwestern University
ClinicalTrials.gov Identifier: NCT02382588     History of Changes
Other Study ID Numbers: 4321
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once the study is completed study results will be shared with the study subjects.

Additional relevant MeSH terms:
Keratitis
Herpes Zoster
Herpes Zoster Ophthalmicus
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Corneal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action