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The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of AL-39256 in patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-39256 | Experimental | AL-39256 Ophthalmic Suspension, 1%, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks. |
|
| XALATAN | Active Comparator | Latanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks. |
|
| Vehicle | Placebo Comparator | Inactive ingredients, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-39256 Ophthalmic Suspension, 1% | Drug |
| ||
| Latanoprost Ophthalmic Solution, 0.005% |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in IOP | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Landry, Ph.D. | Alcon Research | Study Director |
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| Drug |
|
|
| Vehicle | Drug | Inactive ingredients used as a placebo comparator |
|
| 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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