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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002781-66 |
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Project Cancelled
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost/Brinzolamide PM, Vehicle AM | Experimental | Travoprost/Brinzolamide PM, Vehicle AM |
|
| Travoprost/Brinzolamide AM, Vehicle PM | Experimental | Travoprost/Brinzolamide AM, Vehicle PM |
|
| Cosopt | Active Comparator | Cosopt BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost/Brinzolamide | Drug | Eye drop suspension, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP | 9:00,11:00, and 1600 time points at month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12. | All on therapy time points not included in primary efficacy |
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Inclusion Criteria:
IOP at screening visit <18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 &2 visits)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mexico City | 6700 | Mexico |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| C111827 | brinzolamide |
| C479140 | dorzolamide-timolol combination |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Cosopt | Drug | Eye drop solution, one drop BID |
|
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |