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The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xalatan + Azopt | Experimental | Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months. |
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| Xalatan + Placebo | Active Comparator | Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide 1% ophthalmic solution (Azopt) | Drug | One drop three times a day in both eyes for 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | Day 0, 3 months |
| Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | Day 0, 3 months |
| Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | Day 0, 3 months |
| Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months | Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure. | Day 0, 3 months |
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Inclusion Criteria:
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
This reporting group includes all enrolled subjects.
Eligible glaucoma patients were recruited and enrolled from 7 US study sites between Oct 15, 2007 and April 06, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Xalatan + Azopt | Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months. |
| FG001 | Xalatan + Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo eye drops | Drug | One drop three times a day in both eyes for 3 months |
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| Latanoprost 0.005% ophthalmic solution (Xalatan) | Drug | One drop once a day in both eyes for 3 months |
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Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
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| ID | Title | Description |
|---|---|---|
| BG000 | Xalatan + Azopt | Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months. |
| BG001 | Xalatan + Placebo | Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1). | Posted | Mean | Standard Deviation | mmHg | Day 0, 3 months |
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| Primary | Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1). | Posted | Mean | Standard Deviation | mmHg | Day 0, 3 months |
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| Primary | Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1). | Posted | Mean | Standard Deviation | mmHg | Day 0, 3 months |
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| Primary | Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months | Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure. | All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1). | Posted | Mean | Standard Deviation | mmHg | Day 0, 3 months |
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Adverse events were collected for the duration of the study: 15-OCT-2007 to 31-JUL-2009.
The safety population included all enrolled and exposed subjects.
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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 | Xalatan + Azopt | Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months. | 0 | 42 | 0 | 42 | ||
| EG001 | Xalatan + Placebo | Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months. | 0 | 44 | 0 | 44 |
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Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Global Medical Affairs | Alcon Research, Ltd. | 800-862-5266 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D009883 | Ophthalmic Solutions |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Male |
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