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The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-37807 | Experimental | AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks |
|
| Timolol | Active Comparator | Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks |
|
| AL-37807 vehicle | Placebo Comparator | AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-37807 ophthalmic suspension, 0.1% | Drug |
| ||
| Timolol gel forming solution, 0.5% |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in intraocular pressure | Baseline, up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center at 1-888-451-3937 | Fort Worth | Texas | 76134 | United States |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Drug |
|
| AL-37807 ophthalmic solution vehicle | Other |
|
| Latanoprost ophthalmic solution | Drug |
|
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |