Trial Outcomes & Findings for Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis (NCT NCT02382588)

NCT ID: NCT02382588

Last Updated: 2021-07-08

Results Overview

Based on weekly slitlamp photographs

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

2 weeks

Results posted on

2021-07-08

Participant Flow

Per review of consent and drug diaries, 8 subjects were enrolled.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gancyclovir Gel n=4 Participants 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.	Hypromellose Gel n=4 Participants 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 n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	4 Participants n=4 Participants	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	3 Participants n=4 Participants	7 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	4 participants n=4 Participants	8 participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

Based on weekly slitlamp photographs

Outcome measures

Outcome data not reported

Adverse Events

Gancyclovir Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypromellose Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Feder

Northwestern Universtiy

Phone: 3126958150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place