Not provided
Not provided
Not provided
Not provided
Not provided
There were difficulties meeting the enrollment goal within stipulated time frames.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gancyclovir gel | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gancyclovir gel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Ulcer Healing | Based on weekly slitlamp photographs | 2 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18243930 | Background | Liesegang TJ. Herpes zoster ophthalmicus natural history, risk factors, clinical presentation, and morbidity. Ophthalmology. 2008 Feb;115(2 Suppl):S3-12. doi: 10.1016/j.ophtha.2007.10.009. | |
| 185734 | Background | Ostler HB, Thygeson P. The ocular manifestations of herpes zoster, varicella, infectious mononucleosis, and cytomegalovirus disease. Surv Ophthalmol. 1976 Sep-Oct;21(2):148-59. doi: 10.1016/0039-6257(76)90092-8. |
Not provided
Not provided
Once the study is completed study results will be shared with the study subjects.
Not provided
Not provided
Not provided
Not provided
Per review of consent and drug diaries, 8 subjects were enrolled.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Corneal Ulcer Healing | Based on weekly slitlamp photographs | 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. | Posted | 2 weeks |
|
Throughout each patient's participation. 4 visits throughout a maximum of 2 months.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Feder | Northwestern Universtiy | 3126958150 | r-feder@northwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2019 | May 19, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Hypromellose gel | Drug | 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. |
|
|
| 3873048 | Background | Liesegang TJ. Corneal complications from herpes zoster ophthalmicus. Ophthalmology. 1985 Mar;92(3):316-24. doi: 10.1016/s0161-6420(85)34034-4. |
| 6333319 | Background | Trousdale MD, Nesburn AB, Willey DE, Taaid H. Efficacy of BW759 (9-[[2-hydroxy-1(hydroxymethyl)ethoxy]methyl]guanine) against herpes simplex virus type 1 keratitis in rabbits. Curr Eye Res. 1984 Aug;3(8):1007-15. doi: 10.3109/02713688409011747. |
| 12790345 | Background | Villarreal EC. Current and potential therapies for the treatment of herpes-virus infections. Prog Drug Res. 2003;60:263-307. doi: 10.1007/978-3-0348-8012-1_8. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |