An observational study in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in Austria. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2014-06-13.
Sponsored by Allergan · Observational
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 419 is above the median of 103 across 454 observational studies indexed under Glaucoma.
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Patients with POAG and OHT
Exclusion Criteria:
Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
Drug: bimatoprost 0.01% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.
Also known as: Lumigan® 0.01%
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.
Time frame: 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.
Time frame: Week 14
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.
Time frame: Week 14
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 14
| Milestone | Lumigan® 0.01% |
|---|---|
| Started | 419 |
| Completed | 386 |
| Not completed | 33 |
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.
| Millimeters of Mercury (mmHg) | Lumigan® 0.01% |
|---|---|
| Right Eye | 21.23 ± 4.72 |
| Left Eye (n=389) | 21.38 ± 4.51 |
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.
| Eyes | Lumigan® 0.01% |
|---|---|
| IOP lower than target | 83 |
| Target IOP reached | 233 |
| IOP decreased but target not reached | 73 |
| IOP increased | 6 |
| No change | 13 |
| Data Missing | 28 |
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.
| Patients | Lumigan® 0.01% |
|---|---|
| Very Good | 201 |
| Good | 167 |
| Moderate | 16 |
| Poor | 9 |
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.
| Patients | Lumigan® 0.01% |
|---|---|
| Very Good | 209 |
| Good | 171 |
| Moderate | 8 |
| Poor | 4 |
Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.
| Percentage of Patients | Lumigan® 0.01% |
|---|---|
| Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment | 7.9 |
Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.
| Percentage of Patients | Lumigan® 0.01% |
|---|---|
| Percentage of Patients Who Continue Lumigan® 0.01% Treatment | 86.2 |
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.
| Patients | Lumigan® 0.01% |
|---|---|
| Better | 94 |
| Equal | 88 |
| Worse | 1 |
| Not Applicable | 1 |
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.
| Millimeters of Mercury | Lumigan® 0.01% |
|---|---|
| Right Eye | 15.92 ± 2.71 |
| Left Eye (n=389) | 16.05 ± 2.73 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lumigan® 0.01% | — | 0/419 (0%) | 57/419 (13.6%) |
| Event | Lumigan® 0.01% |
|---|---|
| Conjunctival HyperaemiaEye disorders | 36/419 |
| Eye IrritationEye disorders | 21/419 |
| Age, Customized(Participants) | Lumigan® 0.01% |
|---|---|
| <18 years | 0 |
| 18 to 30 years | 1 |
| 31 to 40 years | 7 |
| 41 to 50 years | 33 |
| 51 to 60 years | 66 |
| 61 to 70 years | 137 |
| 71 to 80 years | 116 |
| 81 to 90 years | 51 |
| >=91 years | 4 |
| Missing | 4 |
| Sex/Gender, Customized(Participants) | Lumigan® 0.01% |
|---|---|
| Female | 232 |
| Male | 183 |
| Missing | 4 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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