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This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumigan® 0.01% | Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost 0.01% ophthalmic solution | Drug | Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. |
|
| 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 eye at Baseline. | Baseline |
| Intraocular Pressure (IOP) at Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Evaluation of Efficacy Using a 5-Point Scale | The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported. | Week 12 |
| Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed 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 |
|---|---|---|---|---|---|---|
| Bülach | Canton of Zurich | Switzerland |
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. There was no investigational drug administered in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumigan® 0.01% | Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumigan® 0.01% | Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. |
| 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 eye at Baseline. | All participants with complete data available for IOP. | Posted | Median | Full Range | mm Hg | Baseline |
|
|
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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% | Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (15.1) | 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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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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|
Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported. |
| Week 12 |
| Physician Evaluation of Tolerability of Treatment | The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported. | Week 12 |
| Physician Reported Reasons for Early Discontinuation of Treatment | The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. | 12 Weeks |
| Number of Patients Continuing Treatment After 12 Weeks | The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment? | Week 12 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Physician Evaluation of Efficacy Using a 5-Point Scale | The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported. | All participants with data available for this outcome measure. | Posted | Number | Participants | Week 12 | Eyes | Participants |
|
|
|
| Secondary | Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale | Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported. | All participants with data available for this outcome measure. | Posted | Number | Participants | Week 12 |
|
|
|
| Secondary | Physician Evaluation of Tolerability of Treatment | The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported. | All participants with data available for this outcome measure. | Posted | Number | Participants | Week 12 |
|
|
|
| Secondary | Physician Reported Reasons for Early Discontinuation of Treatment | The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. | All participants who discontinued treatment early. | Posted | Number | Participants | 12 Weeks |
|
|
|
| Secondary | Number of Patients Continuing Treatment After 12 Weeks | The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment? | All participants with data available for this outcome measure. | Posted | Number | Participants | Week 12 |
|
|
|
| Primary | Intraocular Pressure (IOP) at Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement. | All participants with complete data available for IOP. | Posted | Median | Full Range | mm Hg | Week 12 |
|
|
|
| 0 |
| 387 |
| 148 |
| 387 |
| Eye irritation | Eye disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (15.1) | 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 |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Title | Measurements |
|---|---|
|
| Physician decision to withdraw patient from study |
|
| Patient lost to follow up |
|
| Other reason |
|
| Missing data |
|