Herpes Zoster Keratitis
Conditions
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.
Interventions
DRUGgancyclovir 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.
DRUGHypromellose 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.
Sponsors
Bausch & Lomb Incorporated
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Ulcer Healing | 2 weeks | Based on weekly slitlamp photographs |
Countries
United States
Participant flow
Pre-assignment details
Per review of consent and drug diaries, 8 subjects were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 4 |
| 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.
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. | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Hypromellose Gel | Total | Gancyclovir Gel |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 8 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Corneal Ulcer Healing
Based on weekly slitlamp photographs
Time frame: 2 weeks
Population: 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.