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The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the treatment of primary open-angle glaucoma or intraocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BREMEN eye drops | Experimental | 1 drop in affected eye(s), each 12 hours for 8 weeks. |
|
| Combigan® | Active Comparator | 1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BREMEN eye drops | Drug | 1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated through the adverse events occurrences | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegisa | Campinas | São Paulo | 13.084-791 | Brazil |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| ID | Term |
|---|---|
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| ID | Term |
|---|---|
| D013999 | Timolol |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Combigan® | Drug | 1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks. |
|
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068438 | Brimonidine Tartrate |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |