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The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DuoTrav | Experimental | One drop in study eye(s) once daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®) | Drug | One drop in study eye(s) once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline) | Goldmann applanation tonometry will be performed at the baseline visit and 8-week visit to record intraocular pressure (IOP). The difference between the two readings will be recorded as the change in IOP. IOP will be recorded in mmHg. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who reach target IOP (≤18 mmHg) | Goldmann applanation tonometry will be performed at the 8-week visit to record intraocular pressure. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18 mmHg to the overall study population. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schweinfurt | 97421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21773673 | Result | Scherzer ML, Liehneova I, Negrete FJ, Schnober D. Travoprost 0.004%/timolol 0.5% fixed combination in patients transitioning from fixed or unfixed bimatoprost 0.03%/timolol 0.5%. Adv Ther. 2011 Aug;28(8):661-70. doi: 10.1007/s12325-011-0043-z. Epub 2011 Jul 15. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D013999 | Timolol |
| C571754 | Duotrav |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| 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 |