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The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZARGA | Experimental | Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide 1% and timolol 0.5% fixed combination eye drops | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) | As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy | As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants. | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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Subjects were recruited from 3 study centers in Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZARGA | Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZARGA | Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) | As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants. | Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria. | Posted | Mean | Standard Deviation | millimeters mercury (mmHg) | Baseline, Week 8 |
|
Adverse events were collected for the duration of the study (e.g., 10 months, 8 days). Individual adverse events were captured from the time of first administration of test article to the end-of-study visit (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 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abayomi Ogundele, Pharm.D | Alcon Global Medical Affairs | 1-888-451-3937 |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D013999 | Timolol |
| C571752 | Azarga |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy | As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants. | Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria. | Posted | Number | Percentage of Participants | Week 8 |
|
|
|
| 0 |
| 74 |
| 5 |
| 74 |
Alcon reserves the right to review the results communication prior to its public release.
| 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 |