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This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | brimonidine/timolol Fixed-combination monotherapy |
|
| 2 | Active Comparator | dorzolamide/timolol fixed-combination monotherapy |
|
| 3 | Active Comparator | prostaglandin analogue + brimonidine/timolol fixed combination |
|
| 4 | Active Comparator | prostaglandin analogue + dorzolamide/timolol fixed combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination | Drug | 1 drop BID in each eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean IOP | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient tolerability/comfort measured by Likert scale | Month 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrie | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19476406 | Derived | Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009 Jul;25(7):1645-53. doi: 10.1185/03007990902994041. |
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| dorzolamide hcl 2%/timolol maleate 0.5% fixed combination | Drug | 1 drop BID in each eye |
|
|
| brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy | Drug | 1 drop BID in each eye |
|
|
| dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy | Drug | 1 drop BID in each eye |
|
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D013999 | Timolol |
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| C062765 | dorzolamide |
| C479140 | dorzolamide-timolol combination |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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