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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPA-6566 low dose | Experimental | Treatment with OPA-6566 low dose |
|
| OPA-6566 medium dose | Experimental | Treatment with OPA-6566 medium dose |
|
| OPA-6566 high dose | Experimental | Treatment with OPA-6566 high dose |
|
| Latanoprost | Active Comparator | Treatment with Latanoprost |
|
| Placebo | Placebo Comparator | Placebo |
|
| OPA-6566 additional dose | Experimental | Treatment with OPA-6566 additional dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPA-6566 | Drug | OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine. | 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pharmacokinetics | 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28) | |
| Efficacy: measurement of change in intraocular pressure from baseline. | 28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Chandler, MD | Kubota Vision Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | 90701 | United States | |||
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| Placebo | Drug | Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks) |
|
| Latanoprost | Drug | Latanoprost (one drop once per day for 4 weeks) |
|
| Glendale |
| California |
| 91205 |
| United States |
| Roswell | Georgia | 30076 | United States |
| Louisville | Kentucky | 40217 | United States |
| Washington | Missouri | 63090 | United States |
| High Point | North Carolina | 27262 | United States |
| Maryville | Tennessee | 37803 | United States |
| Austin | Texas | 78731 | United States |
| San Antonio | Texas | 78240 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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