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The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.
This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIMBRINZA™ | Experimental | Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks |
|
| Timolol Maleate 0.5% | Active Comparator | Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension | Drug | Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Nocturnal IOP at Week 4 | Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study 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). | Week 4: 10PM, 12AM, 2AM, 4AM, 6AM |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diurnal IOP at Week 4 | Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danyel Carr, MS | Alcon Research | Study Director |
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Of the 89 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (86).
Participants were recruited from 1 study center located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Simbrinza | 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks |
| FG001 | Timolol | 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Simbrinza | 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks |
| BG001 | Timolol | 1 drop twice a day (8AM, 8PM) in each eye for 4 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 | Mean Nocturnal IOP at Week 4 | Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study 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). | This analysis population includes all participants who received study medication and had at least one on-therapy study visit. | Posted | Mean | Standard Deviation | mmHg | Week 4: 10PM, 12AM, 2AM, 4AM, 6AM |
|
Adverse events (AEs) were collected for the duration of the study (28 Oct 2013 - 03 Mar 2014). Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. This analysis group includes all participants who received study medication.
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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 | Simbrinza | 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Hubatsch, Global Brand Leader, Medical Affairs, Glaucoma | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D000068438 | Brimonidine Tartrate |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Timolol Maleate 0.5% | Drug | Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension. |
|
|
| Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM |
| Mean 24-hour IOP at Week 4 | 24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study 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). | Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Timolol |
1 drop twice a day (8AM, 8PM) in each eye for 4 weeks |
|
|
| Secondary | Mean Diurnal IOP at Week 4 | Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study 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). | This analysis population includes all participants who received study medication and had at least one on-therapy study visit. | Posted | Mean | Standard Deviation | mmHg | Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM |
|
|
|
| Secondary | Mean 24-hour IOP at Week 4 | 24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study 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). | This analysis population includes all participants who received study medication and had at least one on-therapy study visit. | Posted | Mean | Standard Deviation | mmHg | Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Timolol | 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks | 0 | 42 | 0 | 42 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| 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 |
| D009025 | Morpholines |
| D010078 | Oxazines |