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| ID | Type | Description | Link |
|---|---|---|---|
| 037-101 |
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The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | One drop in each eye every 12 hours for seven days |
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| Arm 2 | Experimental | One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
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| Arm 3 | Experimental | One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
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| Arm 4 | Experimental | One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | One drop in each eye every 12 hours for seven days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 15 | |
| Rate of discontinuation | 15 | |
| Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters | 15 | |
| Compliance | 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Haque, MD, PhD | Medical Monitor, Inspire | Study Director |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| INS117548 |
| Drug |
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
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| INS117548 | Drug | One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
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| INS117548 | Drug | One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
|