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To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | bimatoprost 0.03% latanoprost 0.005% travoprost 0.004% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004% | Drug | 1 drop in eye(s) every evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement). | Baseline, 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients can be either: (a) newly diagnosed and require, in the judgment of the treating physician, one of study agents as first-line treatment, (b) have an insufficiently controlled IOP on their current medication (any but not more than two in combination), and a treatment switch to one of study agents is an acceptable option.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Murfreesboro | Tennessee | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumigan® | bimatoprost 0.03% |
| FG001 | Travatan® | travoprost 0.004% |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline |
|
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| Xalatan® |
latanoprost 0.005% |
| COMPLETED |
|
| NOT COMPLETED |
|
| 1 Year Follow-up |
|
| 2 Year Follow-up |
|
| 3 Year Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumigan® | bimatoprost 0.03% |
| BG001 | Travatan® | travoprost 0.004% |
| BG002 | Xalatan® | latanoprost 0.005% |
| BG003 | 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 | Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement). | Intent-to-treat, which includes all patients who started the study and completed the one-year follow-up visit and whose data was available for this outcome measure. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline, 1 Year |
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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 | Lumigan® | bimatoprost 0.03% | 5 | 364 | 0 | 364 | ||
| EG001 | Travatan® | travoprost 0.004% | 2 | 370 | 0 | 370 | ||
| EG002 | Xalatan® | latanoprost 0.005% | 6 | 365 | 0 | 365 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Causes of Death not specified |
|
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Data for 2-year and 3-year follow-up not interpretable due to extremely high drop out rates.
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, Global Health Outcomes Strategy and Research | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D000077338 | Latanoprost |
| D000069557 | Travoprost |
| 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 |
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| Male |
|
|