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difficulty of enrolling patients
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To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost 0.004% + Brinzolamide 1.0% | Experimental | Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) |
|
| Travoprost 0.004% + Tears Natural | Active Comparator | Travoprost 0.004% (once daily) + Tears Naturale (twice daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% + Brinzolamide 1.0% | Drug | Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP (Intraocular Pressure) | Screening: Week 12; (At 9 am and 4 pm time points) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost 0.004% + Brinzolamide 1.0% | Travoprost 0.004% + Brinzolamide 1.0% |
| FG001 | Travoprost 0.004% + Tears Natural | Travoprost 0.004% + Tears Natural |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Travoprost 0.004% + Brinzolamide 1.0% | Travoprost 0.004% + Brinzolamide 1.0% |
| BG001 | Travoprost 0.004% + Tears Natural | Travoprost 0.004% + Tears Natural |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean IOP (Intraocular Pressure) | Posted | Mean | Standard Deviation | mm Hg (millimeters mercury) | Screening: Week 12; (At 9 am and 4 pm time points) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Travoprost 0.004% + Brinzolamide 1.0% | Travoprost 0.004% + Brinzolamide 1.0% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Travoprost 0.004% + Tears Natural | Drug | Travoprost 0.004% (once daily) + Tears Naturale (twice daily) |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Travoprost 0.004% + Tears Natural | Travoprost 0.004% + Tears Natural | 0 | 18 | 0 | 18 |
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Confidentiality agreement
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |