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An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost | Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost | Drug | Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 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 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12. | Week 12 |
| 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 12 |
| Patient Assessment of Tolerability on a 4-Point Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with POAG and OHT
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dresden | Germany | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost | Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost | Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 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 | Bimatoprost | Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 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 |
| C571755 | Ganfort |
| 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 12 |
| 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 12 |
| 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 12 |
| Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment | Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No. | 12 Weeks |
| Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops | Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No. | Week 12 |
| Amsterdam |
| Netherlands |
| 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 12 | 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 12 |
|
|
|
| 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 12 |
|
|
|
| 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 12 |
|
|
|
| Secondary | Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment | Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No. | All patients | Posted | Number | Percentage of Patients | 12 Weeks |
|
|
|
| Secondary | Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops | Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No. | All patients | Posted | Number | Percentage of Patients | Week 12 |
|
|
|
| Primary | IOP at Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12. | All patients with data for this outcome measure | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Week 12 |
|
|
|
| 0 |
| 2,580 |
| 450 |
| 2,580 |
| 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 |
| Title | Measurements |
|---|---|
|
| IOP increased |
|
| No change |
|
| Data Missing |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Title | Measurements |
|---|
|
| Not Applicable |
|