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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 : March 13, 2019
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Robert Feder, Northwestern University

Tracking Information
First Submitted Date  ICMJE March 3, 2015
First Posted Date  ICMJE March 6, 2015
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
Healing based on weekly slitlamp photographs [ Time Frame: 2 weeks ]
Based on weekly slitlamp photographs
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02382588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Herpes Zoster Keratitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: gancyclovir gel
  • 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.
    Intervention: Drug: Hypromellose gel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Robert S Feder, MD, MBA 312-695-8150 r-feder@northwestern.edu
Contact: Nicole Seddon 312-695-0252 nreinhol@nm.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02382588
Other Study ID Numbers  ICMJE 4321
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Once the study is completed study results will be shared with the study subjects.
Responsible Party Robert Feder, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Bausch & Lomb Incorporated
Investigators  ICMJE Not Provided
PRS Account Northwestern University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP