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Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combigan ® | Active Comparator | Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%) |
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| Timolol Maleate 0.5% | Active Comparator | Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% | Drug | 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. | Week 6 |
| Mean Intraocular Pressure (IOP) at 8 AM at 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 |
|---|---|---|---|---|---|---|
| Newark | New Jersey | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21792284 | Background | Fechtner RD, Harasymowycz P, Nixon DR, Vold SD, Zaman F, Williams JM, Hollander DA. Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost. Clin Ophthalmol. 2011;5:945-53. doi: 10.2147/OPTH.S19999. Epub 2011 Jul 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combigan® | Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%) |
| FG001 | Timolol Maleate 0.5% | Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| timolol maleate 0.5% | Drug | 1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. |
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| latanoprost 0.005% | Drug | 1 drop of latanoprost 0.005% once nightly. |
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Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.
| Week 12 |
| Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. | Week 6 |
| Number of Subjects With Adverse Events | Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit). | Week 12 |
| Montreal |
| Quebec |
| Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Combigan® | Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%) |
| BG001 | Timolol Maleate 0.5% | Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%) |
| 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 | Median | Full Range | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. | Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Week 6 |
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| Primary | Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye. | Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Week 12 |
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| Secondary | Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye. | Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Week 12 |
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| Secondary | Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. | Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Week 6 |
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| Secondary | Number of Subjects With Adverse Events | Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit). | Safety population, which included all patients who started the study (randomized) and were treated. | Posted | Number | Participants | Week 12 |
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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 | Combigan® | Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%) | 0 | 102 | 0 | 102 | ||
| EG001 | Timolol Maleate 0.5% | Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%) | 2 | 102 | 0 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute exacerbation of COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bacterial bronchitis | Infections and infestations | Systematic Assessment |
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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 |
|---|---|
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| D013999 | Timolol |
| 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 |
| D000068438 | Brimonidine Tartrate |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D009025 | Morpholines |
| D010078 | Oxazines |
| 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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