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A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumigan® 0.01% | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost 0.01% ophthalmic solution | Drug | Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) at Baseline | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline. | Baseline |
| IOP at Week 14 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14. | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented. | Week 14 |
| Patient Assessment of Tolerability on a 4-Point Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with POAG and OHT
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | Austria |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumigan® 0.01% | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumigan® 0.01% | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Baseline | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline. | All patients with data for this outcome measure | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline |
|
|
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All enrolled patients were used to assess adverse events (AEs) and serious adverse events (SAEs).
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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® 0.01% | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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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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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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|
Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. |
| Week 14 |
| Physician Assessment of Tolerability on a 4-Point Scale | Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. | Week 14 |
| Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment | Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No. | 14 Weeks |
| Percentage of Patients Who Continue Lumigan® 0.01% Treatment | Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No. | Week 14 |
| Physician Assessment of Patient Compliance Compared to Previous Therapy | Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented. | Week 14 |
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
|
| Secondary | Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented. | All patients with data for this outcome measure | Posted | Number | Eyes | Week 14 | Eyes | Participants |
|
|
|
| Secondary | Patient Assessment of Tolerability on a 4-Point Scale | Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. | All patients with data for this outcome measure | Posted | Number | Patients | Week 14 |
|
|
|
| Secondary | Physician Assessment of Tolerability on a 4-Point Scale | Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. | All patients with data for this outcome measure | Posted | Number | Patients | Week 14 |
|
|
|
| Secondary | Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment | Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No. | All patients | Posted | Number | Percentage of Patients | 14 Weeks |
|
|
|
| Secondary | Percentage of Patients Who Continue Lumigan® 0.01% Treatment | Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No. | All patients | Posted | Number | Percentage of Patients | Week 14 |
|
|
|
| Secondary | Physician Assessment of Patient Compliance Compared to Previous Therapy | Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented. | All patients with data for this outcome measure | Posted | Number | Patients | Week 14 |
|
|
|
| Primary | IOP at Week 14 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14. | All patients with data for this outcome measure | Posted | Mean | Standard Deviation | Millimeters of Mercury | Week 14 |
|
|
|
| 0 |
| 419 |
| 57 |
| 419 |
| Eye Irritation | Eye disorders | MedDRA version 16.0 | 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.
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| Title | Measurements |
|---|---|
|
| IOP increased |
|
| No change |
|
| Data Missing |
|
| Title |
|---|
| Measurements |
|---|
|
| Poor |
|
| Title |
|---|
| Measurements |
|---|
|
| Poor |
|
| Title | Measurements |
|---|
|
| Not Applicable |
|