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The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.
Glaucoma is a group of diseases of the eye that can result in irreversible vision loss due to damage to the optic nerve. Elevated intraocular pressure (IOP) is one factor associated with glaucoma. Currently-available medication used to lower IOP includes beta-blocking agents, which can have undesirable side effects on the cardiac and respiratory systems.
The OT-730 ophthalmic solution contains OT-730, a prodrug that, when applied as an eyedrop, metabolizes to OT-705, an active beta blocker. The OT-730 ophthalmic solution is being studied to see how well it lowers IOP in patients with a diagnosis of open angle glaucoma or ocular hypertension. It will be compared with a well known beta blocker, timolol maleate ophthalmic solution, and with a placebo eye drop, in order to assess its ability to lower IOP without the typical side effects of other beta blockers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | OT-730 ophthalmic solution |
|
| 2 | Active Comparator | timolol maleate ophthalmic solution |
|
| 3 | Placebo Comparator | placebo eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OT-730 ophthalmic solution | Drug | one eye drop twice daily |
| |
| timolol maleate ophthalmic solution |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety profile of OT-730 | 8 days | |
| Change from baseline in intraocular pressure | Day 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
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| Label | URL |
|---|---|
| Othera Pharmaceuticals, Inc. website | View source |
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| Drug |
one eye drop twice daily |
|
| OT-730 placebo | Drug | one eye drop twice daily |
|
| Roswell |
| Georgia |
| United States |
| Charlotte | North Carolina | United States |
| High Point | North Carolina | United States |
| Mt. Pleasant | South Carolina | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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