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This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POAG or OHT | Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost 0.01% | Drug | Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. | Baseline, 14 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Tolerability Using a 4-Point Scale | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. | 14 Weeks |
| Physician Assessment of Tolerability Using a 4-Point Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary open angle glaucoma or ocular hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | POAG or OHT | Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | POAG or OHT | Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry |
| 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 | Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. | All enrolled patients with complete data for this outcome measure | Posted | Median | Inter-Quartile Range | Millimeters of Mercury (mmHg) | Baseline, 14 Weeks |
|
|
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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 | POAG or OHT | Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. |
| 14 Weeks |
| Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks | Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No. | 14 Weeks |
| Patients Who Will Continue Use of Lumigan® After 14 Weeks | Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No. | 14 Weeks |
| Years |
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| Sex/Gender, Customized | Number | Participants |
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| Secondary | Patient Assessment of Tolerability Using a 4-Point Scale | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. | All enrolled patients with complete data for this outcome measure | Posted | Number | Participants | 14 Weeks |
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| Secondary | Physician Assessment of Tolerability Using a 4-Point Scale | Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. | All enrolled patients with complete data for this outcome measure | Posted | Number | Participants | 14 Weeks |
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| Secondary | Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks | Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No. | All enrolled patients with complete data for this outcome measure | Posted | Number | Participants | 14 Weeks |
|
|
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| Secondary | Patients Who Will Continue Use of Lumigan® After 14 Weeks | Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No. | All enrolled patients with complete data for this outcome measure | Posted | Number | Participants | 14 Weeks |
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| 0 |
| 854 |
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| 854 |
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.