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A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution |
|
| 2 | Active Comparator | Latanoprost 0.005% ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution | Drug | 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) at Week 12 | Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slingerlands | New York | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22458918 | Derived | Katz LJ, Rauchman SH, Cottingham AJ Jr, Simmons ST, Williams JM, Schiffman RM, Hollander DA. Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study. Curr Med Res Opin. 2012 May;28(5):781-8. doi: 10.1185/03007995.2012.681036. Epub 2012 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate | Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution |
| FG001 | Latanoprost 0.005% Ophthalmic Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| latanoprost 0.005% | Drug | 1 drop of study medication taken once daily |
|
|
Latanoprost 0.005% ophthalmic solution
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate | Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution |
| BG001 | Latanoprost 0.005% Ophthalmic Solution | Latanoprost 0.005% ophthalmic solution |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Intraocular Pressure (IOP) at Week 12 | Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye. | Intent-to-treat, which included all patients who started the study (randomized). | Posted | Mean | Standard Deviation | Millimeters of mercury (mm Hg) | Week 12 |
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The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
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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 | Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate | Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution | 0 | 73 | 8 | 73 | ||
| EG001 | Latanoprost 0.005% Ophthalmic Solution | Latanoprost 0.005% ophthalmic solution | 1 | 75 | 0 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | COSTART version 6 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | COSTART version 6 | Non-systematic Assessment |
| |
| Pain eye | Eye disorders | COSTART version 6 | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| D009883 | Ophthalmic Solutions |
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| 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 |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D000068438 | Brimonidine Tartrate |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| 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 |
|