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To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications.
The study is to assess the safety and efficacy of a new treatment for ocular surface disease associated with the use of glaucoma medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GL101 | Active Comparator | GL101 topical gel |
|
| Placebo | Placebo Comparator | Placebo topical gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GL101 | Drug | Topical Gel |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Glaucoma medication ocular side effect symptoms | Glaucoma medication ocular side effect symptoms:
| Day 1 to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glaucoma medication ocular side effect signs | Glaucoma medication ocular side effect signs:
| Day 1 to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events:
| Day 1 to 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Ritch, MD | New York Eye & Ear Infirmary of Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Eye & Ear Infirmary of Mount Sinai | New York | New York | 10003 | United States |
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| Placebo |
| Drug |
Placebo topical gel |
|
| Other signs | Other signs:
| Day 1 to 4 weeks |