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| ID | Type | Description | Link |
|---|---|---|---|
| 032-101 |
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The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Arm 1 |
|
| 2 | Experimental | Arm 2 |
|
| 3 | Experimental | Arm 3 |
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| 4 | Experimental | Arm 4 |
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| 5 | Experimental | Arm 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INS115644 Ophthalmic Solution | Drug | One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | 28 days | |
| Changes in intraocular pressure | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo | Drug | One drop of placebo in each eye every 12 hours for three days |
|
| INS115644 Ophthalmic Solution | Drug | One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days |
|
| INS115644 Ophthalmic Solution | Drug | One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days |
|
| INS115644 Ophthalmic Solution | Drug | One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days |
|
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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