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This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimatoprost 0.01% and hypromellose 0.3% | Active Comparator | Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. |
|
| travatan 0.004% and timolol 0.5% | Active Comparator | Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost 0.01% | Drug | Bimatoprost 0.01% administered to both eyes once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements. | Week 12 at 8 AM, 12 PM, and 4 PM |
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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 |
|---|---|---|---|---|---|---|
| Barrie | Ontario | Canada | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost 0.01% and Hypromellose 0.3% | Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. |
| FG001 | Travatan 0.004% and Timolol 0.5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| travatan 0.004% | Drug | Travatan 0.004% administered to both eyes once daily for 12 weeks. |
|
|
| timolol 0.5% | Drug | Timolol 0.5% administered to both eyes once daily for 12 weeks. |
|
|
| hypromellose 0.3% | Drug | Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks. |
|
|
| Toronto |
| Ontario |
| Canada |
Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost 0.01% and Hypromellose 0.3% | Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. |
| BG001 | Travatan 0.004% and Timolol 0.5% | Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks. |
| 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 | Mean | Standard Deviation | 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) in the Study Eye at 8 AM, 12 PM, and 4 PM | IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements. | Intent-to-Treat: all subjects who were randomized to study medication | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Week 12 at 8 AM, 12 PM, and 4 PM |
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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 | Bimatoprost 0.01% and Hypromellose 0.3% | Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. | 1 | 47 | 0 | 47 | ||
| EG001 | Travatan 0.004% and Timolol 0.5% | Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks. | 0 | 46 | 0 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pain | Cardiac disorders | MedDRA version 12.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA version 12.0 | 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 |
|---|---|
| D000069580 | Bimatoprost |
| D000069557 | Travoprost |
| D013999 | Timolol |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| 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 |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| 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 |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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| Male |
|
| Week 12 at 4 PM |
|