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The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo ophthalmic solution | Placebo Comparator | Eyedrop |
|
| DE-117 ophthalmic solution low | Experimental | Eyedrop |
|
| DE-117 ophthalmic solution high | Experimental | Eyedrop |
|
| Latanoprost ophthalmic solution 0.005% | Active Comparator | Eyedrop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo ophthalmic solution | Drug |
| ||
| DE-117 ophthalmic solution low |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo, Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32533949 | Derived | Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams NK. Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study. Am J Ophthalmol. 2020 Dec;220:53-63. doi: 10.1016/j.ajo.2020.06.003. Epub 2020 Jun 10. |
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| Drug |
|
| DE-117 ophthalmic solution high | Drug |
|
| Latanoprost ophthalmic solution 0.005% | Drug |
|
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| 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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