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The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with POAG or OHT | Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost Ophthalmic Solution | Drug | Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) in the Study Eye at Baseline | IOP is a measurement of the fluid pressure inside the study eye. | Baseline |
| IOP in the Study Eye at Week 12 | IOP is a measurement of the fluid pressure inside the study eye. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented. | Baseline, 12 Weeks |
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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 |
|---|---|---|---|---|---|---|
| Wiesloch | Baden-Wurttemberg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27672307 | Background | Pillunat LE, Eschstruth P, Hasemeyer S, Thelen U, Foja C, Leaback R, Pfennigsdorf S. Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice. Clin Ophthalmol. 2016 Sep 12;10:1759-65. doi: 10.2147/OPTH.S103084. eCollection 2016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With POAG or OHT | Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With POAG or OHT | Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice 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) in the Study Eye at Baseline | IOP is a measurement of the fluid pressure inside the study eye. | All patients with data for this outcome measure | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline |
|
|
Adverse events (AEs) were collected for 12 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 | Patients With POAG or OHT | Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract Operation | Eye disorders | MedDRA version 16.1 | 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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|
| Patient Assessment of Tolerability on a 4-Point Scale |
Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. |
| 12 Weeks |
| Physician Assessment of Tolerability on a 4-Point Scale | Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. | 12 Weeks |
| Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment | Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No. | 12 Weeks |
| Number of Patients Who Continue Treatment | Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No. | 12 Weeks |
| Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented. | 12 Weeks |
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
|
|
| Secondary | Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented. | All patients with data for this outcome measure | Posted | Number | Patients | Baseline, 12 Weeks |
|
|
|
| Secondary | Patient Assessment of Tolerability on a 4-Point Scale | Patient assessment of tolerability is 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 | 12 Weeks |
|
|
|
| Secondary | Physician Assessment of Tolerability on a 4-Point Scale | Physician assessment of tolerability is 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 | 12 Weeks |
|
|
|
| Secondary | Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment | Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No. | All enrolled patients | Posted | Number | Patients | 12 Weeks |
|
|
|
| Secondary | Number of Patients Who Continue Treatment | Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No. | All enrolled patients | Posted | Number | Patients | 12 Weeks |
|
|
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| Secondary | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Physician assessment of patient compliance compared to previous therapy is 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 | 12 Weeks |
|
|
|
| Primary | IOP in the Study Eye at Week 12 | IOP is a measurement of the fluid pressure inside the study eye. | All patients with data for this outcome measure | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
| 2 |
| 1,830 |
| 0 |
| 1,830 |
| Death | General disorders | MedDRA version 16.1 | 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.
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|
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| Poor |
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| Title | Measurements |
|---|
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| Poor |
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| Title | Measurements |
|---|
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