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The purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost 0.004%/Timolol 0.5% | Experimental | Travoprost 0.004%/Timolol 0.5% in both eyes each morning at 8 a.m. and Timolol vehicle in both eyes each evening at 8 p.m. for 3 months |
|
| Xalatan + Timolol 0.5% | Active Comparator | Timolol 0.5% in both eyes each morning at 8 a.m. and Xalatan in both eyes each evening at 8 p.m. for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution | Drug | Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean intraocular pressure (IOP) change at 3 months from baseline | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Timolol Vehicle | Other | Placebo |
|
| Latanoprost 0.005% Ophthalmic Solution (XALATAN) | Drug | Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension |
|
|
| Timolol Maleate Ophthalmic Solution 0.5% | Drug | Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension |
|
| 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 |
|---|---|
| D000069557 | Travoprost |
| D013999 | Timolol |
| D009883 | Ophthalmic Solutions |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| 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 |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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