Glaucoma, Primary Open Angle, Ocular Hypertension
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosed with primary open-angle glaucoma or ocular hypertension * Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) in the Study Eye at Baseline | Baseline | IOP is a measurement of the fluid pressure inside the study eye. |
| IOP in the Study Eye at Week 12 | Week 12 | IOP is a measurement of the fluid pressure inside the study eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Assessment of Tolerability on a 4-Point Scale | 12 Weeks | 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. |
| Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment | 12 Weeks | Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No. |
| Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | Baseline, 12 Weeks | 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. |
| Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | 12 Weeks | 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. |
| Number of Patients Who Continue Treatment | 12 Weeks | Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No. |
| Patient Assessment of Tolerability on a 4-Point Scale | 12 Weeks | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,830 |
| Total | 1,830 |
Baseline characteristics
| Characteristic | Patients With POAG or OHT |
|---|---|
| Age, Customized 18-30 years | 9 Participants |
| Age, Customized <18 years | 1 Participants |
| Age, Customized 31-40 years | 28 Participants |
| Age, Customized 41-50 years | 130 Participants |
| Age, Customized 51-60 years | 328 Participants |
| Age, Customized 61-70 years | 509 Participants |
| Age, Customized 71-80 years | 601 Participants |
| Age, Customized 81-90 years | 158 Participants |
| Age, Customized ≥ 91 years | 16 Participants |
| Age, Customized Missing Data | 50 Participants |
| Sex/Gender, Customized Female | 1098 Participants |
| Sex/Gender, Customized Male | 723 Participants |
| Sex/Gender, Customized Missing Data | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,830 |
| serious Total, serious adverse events | 2 / 1,830 |
Outcome results
Primary
Intraocular Pressure (IOP) in the Study Eye at Baseline
IOP is a measurement of the fluid pressure inside the study eye.
Time frame: Baseline
Population: All patients with data for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With POAG or OHT | Intraocular Pressure (IOP) in the Study Eye at Baseline | 21.15 Millimeters of Mercury (mmHg) | Standard Deviation 3.43 |
Primary
IOP in the Study Eye at Week 12
IOP is a measurement of the fluid pressure inside the study eye.
Time frame: Week 12
Population: All patients with data for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With POAG or OHT | IOP in the Study Eye at Week 12 | 16.38 mmHg | Standard Deviation 2.93 |
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.
Time frame: 12 Weeks
Population: All enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With POAG or OHT | Number of Patients Who Continue Treatment | 1501 Patients |
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.
Time frame: 12 Weeks
Population: All enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With POAG or OHT | Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment | 139 Patients |
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.
Time frame: 12 Weeks
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Poor | 74 Patients |
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Very Good | 913 Patients |
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Good | 670 Patients |
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Moderate | 73 Patients |
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.
Time frame: Baseline, 12 Weeks
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | Better than Expected | 649 Patients |
| Patients With POAG or OHT | Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | As Expected | 916 Patients |
| Patients With POAG or OHT | Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | Worse than Expected | 151 Patients |
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.
Time frame: 12 Weeks
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Better | 848 Patients |
| Patients With POAG or OHT | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Equal | 777 Patients |
| Patients With POAG or OHT | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Worse | 50 Patients |
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.
Time frame: 12 Weeks
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Very Good | 982 Patients |
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Good | 648 Patients |
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Moderate | 78 Patients |
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Poor | 38 Patients |