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

Sponsor
Northwestern University (Other)
Overall Status
Terminated
CT.gov ID
NCT02382588
Collaborator
Bausch & Lomb Incorporated (Industry)
8
1
2
77
0.1

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
8 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
Actual Study Start Date :
Dec 10, 2013
Actual Primary Completion Date :
May 11, 2020
Actual Study Completion Date :
May 11, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • genteal gel
  • Outcome Measures

    Primary Outcome Measures

    1. Corneal Ulcer Healing [2 weeks]

      Based on weekly slitlamp photographs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University
    • Bausch & Lomb Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Robert Feder, Professor of Ophthalmology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT02382588
    Other Study ID Numbers:
    • 4321
    First Posted:
    Mar 6, 2015
    Last Update Posted:
    Jul 8, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Per review of consent and drug diaries, 8 subjects were enrolled.
    Arm/Group Title Gancyclovir Gel Hypromellose Gel
    Arm/Group Description 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. 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. 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. 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.
    Period Title: Overall Study
    STARTED 4 4
    COMPLETED 4 4
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Gancyclovir Gel Hypromellose Gel Total
    Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
    Overall Participants 4 4 8
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    4
    100%
    4
    100%
    8
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    1
    25%
    1
    12.5%
    Male
    4
    100%
    3
    75%
    7
    87.5%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    4
    100%
    4
    100%
    8
    100%

    Outcome Measures

    1. Primary Outcome
    Title Corneal Ulcer Healing
    Description Based on weekly slitlamp photographs
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    Report on "Comparison of Topical 0.15% Gancicyclovir Gel vs 0.3% Hypromellose Gel for the treatment of Herpes Zoster keratitis This study was begun in December of 2013 in order to determine if topical ganciclovir 0.15% was beneficial in the treatment of Herpes Zoster keratitis. Despite the number of years the study was open we were only able to recruit 8 subjects. Data was not summarized due to privacy concerns for participants due to low enrollment The study was closed in May of 2020.
    Arm/Group Title Gancyclovir Gel Hypromellose Gel
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 0 0

    Adverse Events

    Time Frame Throughout each patient's participation. 4 visits throughout a maximum of 2 months.
    Adverse Event Reporting Description Report on "Comparison of Topical 0.15% Gancicyclovir Gel vs 0.3% Hypromellose Gel for the treatment of Herpes Zoster keratitis This study was begun in December of 2013 in order to determine if topical ganciclovir 0.15% was beneficial in the treatment of Herpes Zoster keratitis. Unfortunately despite the number of years the study was open we were only able to recruit 7 subjects into the study. This was not enough to provide meaningful results. The study was closed in May of 2020.
    Arm/Group Title Gancyclovir Gel Hypromellose Gel
    Arm/Group Description 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. 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. 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. 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.
    All Cause Mortality
    Gancyclovir Gel Hypromellose Gel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/4 (0%)
    Serious Adverse Events
    Gancyclovir Gel Hypromellose Gel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/4 (0%)
    Other (Not Including Serious) Adverse Events
    Gancyclovir Gel Hypromellose Gel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/4 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Robert Feder
    Organization Northwestern Universtiy
    Phone 3126958150
    Email r-feder@northwestern.edu
    Responsible Party:
    Robert Feder, Professor of Ophthalmology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT02382588
    Other Study ID Numbers:
    • 4321
    First Posted:
    Mar 6, 2015
    Last Update Posted:
    Jul 8, 2021
    Last Verified:
    Jun 1, 2021