Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.01% ophthalmic solution | Drug | Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician. |
|
| 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 eye and the right eye at Week 12. The lower the IOP values the greater the improvement. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Treatment Tolerability 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 patients assessed in each of the categories is reported. | 12 weeks |
| Physician Assessment of Treatment Tolerability Using a 4-Point Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with POAG or OHT
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent | Oost-Vlaanderen | Belgium |
This was an observational study of participants who received Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) at a dose and frequency as determined by the physician prior to entry into the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age data was not available for 37 patients. |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Patient Assessment of Treatment Tolerability 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 patients assessed in each of the categories is reported. | All patients with data available for this outcome measure. | Posted | Number | Participants | 12 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | MedDRA (15.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
Not provided
Not provided
Not provided
Not provided
Not provided
|
The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported. |
| 12 weeks |
| Physician Reported Reasons for Treatment Discontinuation | 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? | 12 weeks |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Number | Participants |
|
|
|
| Secondary | Physician Assessment of Treatment Tolerability Using a 4-Point Scale | The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported. | All patients with data available for this outcome measure. | Posted | Number | Participants | 12 weeks |
|
|
|
| Secondary | Physician Reported Reasons for Treatment Discontinuation | The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. | All patients with data available for this outcome measure. | 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 patients with data available for this outcome measure. | Posted | Number | Participants | 12 weeks |
|
|
|
| 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 patients with complete data available for IOP. | Posted | Mean | Standard Deviation | mm Hg | Baseline |
|
|
|
| Primary | Intraocular Pressure (IOP) at Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement. | All patients with complete data available for IOP. | Posted | Mean | Standard Deviation | mm Hg | Week 12 |
|
|
|
| 7 |
| 933 |
| 53 |
| 933 |
| Vein disorder | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Nightmare | Psychiatric 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 |
|---|
|
| Poor |
|
| Title | Measurements |
|---|
|
| Patient decision to withdraw from study |
|
| Physician decision to withdraw patient from study |
|
| Other reason |
|