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Low recruitment rate
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The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZARGA | Experimental | Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide/timolol maleate fixed combination | Drug | Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy). | Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doug Hubatsch, M.Sc. | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | São Paulo | 11045-140 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZARGA | Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AZARGA | Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy). | Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Posted | Mean | Standard Deviation | millimeters mercury (mmHg) | 8 weeks |
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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 | AZARGA | Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks | 0 | 9 | 0 | 9 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Hubatsch, Global Brand Leader, Medical Affairs | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| C571752 | Azarga |
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