Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
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.
Interventions
Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of POAG or OHT * Prescribed Lumigan® 0.01%
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) at Baseline | Baseline | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline. |
| IOP at Week 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Assessment of Tolerability on a 4-Point Scale | Week 14 | 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. |
| Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment | 14 Weeks | Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No. |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | Week 14 | 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. |
| Physician Assessment of Patient Compliance Compared to Previous Therapy | Week 14 | 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. |
| Percentage of Patients Who Continue Lumigan® 0.01% Treatment | Week 14 | Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No. |
| Patient Assessment of Tolerability on a 4-Point Scale | Week 14 | 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. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lumigan® 0.01% Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks. | 419 |
| Total | 419 |
Baseline characteristics
| Characteristic | Lumigan® 0.01% |
|---|---|
| Age, Customized 18 to 30 years | 1 Participants |
| Age, Customized <18 years | 0 Participants |
| Age, Customized 31 to 40 years | 7 Participants |
| Age, Customized 41 to 50 years | 33 Participants |
| Age, Customized 51 to 60 years | 66 Participants |
| Age, Customized 61 to 70 years | 137 Participants |
| Age, Customized 71 to 80 years | 116 Participants |
| Age, Customized 81 to 90 years | 51 Participants |
| Age, Customized >=91 years | 4 Participants |
| Age, Customized Missing | 4 Participants |
| Sex/Gender, Customized Female | 232 Participants |
| Sex/Gender, Customized Male | 183 Participants |
| Sex/Gender, Customized Missing | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 57 / 419 |
| serious Total, serious adverse events | 0 / 419 |
Outcome results
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 eyes at Baseline.
Time frame: Baseline
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lumigan® 0.01% | Intraocular Pressure (IOP) at Baseline | Right Eye | 21.23 Millimeters of Mercury (mmHg) | Standard Deviation 4.72 |
| Lumigan® 0.01% | Intraocular Pressure (IOP) at Baseline | Left Eye (n=389) | 21.38 Millimeters of Mercury (mmHg) | Standard Deviation 4.51 |
Primary
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
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lumigan® 0.01% | IOP at Week 14 | Left Eye (n=389) | 16.05 Millimeters of Mercury | Standard Deviation 2.73 |
| Lumigan® 0.01% | IOP at Week 14 | Right Eye | 15.92 Millimeters of Mercury | Standard Deviation 2.71 |
Secondary
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
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumigan® 0.01% | Patient Assessment of Tolerability on a 4-Point Scale | Very Good | 201 Patients |
| Lumigan® 0.01% | Patient Assessment of Tolerability on a 4-Point Scale | Good | 167 Patients |
| Lumigan® 0.01% | Patient Assessment of Tolerability on a 4-Point Scale | Moderate | 16 Patients |
| Lumigan® 0.01% | Patient Assessment of Tolerability on a 4-Point Scale | Poor | 9 Patients |
Secondary
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
Population: All patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumigan® 0.01% | Percentage of Patients Who Continue Lumigan® 0.01% Treatment | 86.2 Percentage of Patients |
Secondary
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
Population: All patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumigan® 0.01% | Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment | 7.9 Percentage of Patients |
Secondary
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
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumigan® 0.01% | Physician Assessment of Patient Compliance Compared to Previous Therapy | Better | 94 Patients |
| Lumigan® 0.01% | Physician Assessment of Patient Compliance Compared to Previous Therapy | Equal | 88 Patients |
| Lumigan® 0.01% | Physician Assessment of Patient Compliance Compared to Previous Therapy | Worse | 1 Patients |
| Lumigan® 0.01% | Physician Assessment of Patient Compliance Compared to Previous Therapy | Not Applicable | 1 Patients |
Secondary
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
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumigan® 0.01% | Physician Assessment of Tolerability on a 4-Point Scale | Very Good | 209 Patients |
| Lumigan® 0.01% | Physician Assessment of Tolerability on a 4-Point Scale | Good | 171 Patients |
| Lumigan® 0.01% | Physician Assessment of Tolerability on a 4-Point Scale | Moderate | 8 Patients |
| Lumigan® 0.01% | Physician Assessment of Tolerability on a 4-Point Scale | Poor | 4 Patients |
Secondary
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
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumigan® 0.01% | Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP lower than target | 83 Eyes |
| Lumigan® 0.01% | Physician Evaluation of IOP Lowering in the Study Eye(s) | Target IOP reached | 233 Eyes |
| Lumigan® 0.01% | Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP decreased but target not reached | 73 Eyes |
| Lumigan® 0.01% | Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP increased | 6 Eyes |
| Lumigan® 0.01% | Physician Evaluation of IOP Lowering in the Study Eye(s) | No change | 13 Eyes |
| Lumigan® 0.01% | Physician Evaluation of IOP Lowering in the Study Eye(s) | Data Missing | 28 Eyes |