Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.
Interventions
DRUGBimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of POAG or OHT * Previous use of IOP-lowering medication
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 12 | Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Assessment of Tolerability on a 4-Point Scale | Week 12 | 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. |
| Physician Assessment of Patient Compliance Compared to Previous Therapy | Week 12 | 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. |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | Week 12 | 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. |
| Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops | Week 12 | Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No. |
| Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment | 12 Weeks | Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No. |
| Patient Assessment of Tolerability on a 4-Point Scale | Week 12 | 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
Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks. | 2,580 |
| Total | 2,580 |
Baseline characteristics
| Characteristic | Bimatoprost |
|---|---|
| Age, Customized 18 to 30 years | 12 Participants |
| Age, Customized <18 years | 0 Participants |
| Age, Customized 31 to 40 years | 20 Participants |
| Age, Customized 41 to 50 years | 178 Participants |
| Age, Customized 51 to 60 years | 403 Participants |
| Age, Customized 61 to 70 years | 695 Participants |
| Age, Customized 71 to 80 years | 883 Participants |
| Age, Customized 81 to 90 years | 342 Participants |
| Age, Customized >=91 years | 19 Participants |
| Age, Customized Missing | 28 Participants |
| Sex/Gender, Customized Female | 1454 Participants |
| Sex/Gender, Customized Male | 1115 Participants |
| Sex/Gender, Customized Missing | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 450 / 2,580 |
| serious Total, serious adverse events | 0 / 2,580 |
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 |
|---|---|---|---|---|
| Bimatoprost | Intraocular Pressure (IOP) at Baseline | Right Eye | 20.51 Millimeters of Mercury (mmHg) | Standard Deviation 4.32 |
| Bimatoprost | Intraocular Pressure (IOP) at Baseline | Left Eye (n=2091) | 20.65 Millimeters of Mercury (mmHg) | Standard Deviation 4.54 |
Primary
IOP at Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.
Time frame: Week 12
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost | IOP at Week 12 | Right Eye | 15.78 Millimeters of Mercury (mmHg) | Standard Deviation 2.85 |
| Bimatoprost | IOP at Week 12 | Left Eye (n=2091) | 15.87 Millimeters of Mercury (mmHg) | Standard Deviation 3.19 |
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 12
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost | Patient Assessment of Tolerability on a 4-Point Scale | Very Good | 1127 Patients |
| Bimatoprost | Patient Assessment of Tolerability on a 4-Point Scale | Good | 1070 Patients |
| Bimatoprost | Patient Assessment of Tolerability on a 4-Point Scale | Moderate | 80 Patients |
| Bimatoprost | Patient Assessment of Tolerability on a 4-Point Scale | Poor | 70 Patients |
Secondary
Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops
Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.
Time frame: Week 12
Population: All patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost | Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops | 85.8 Percentage of Patients |
Secondary
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.
Time frame: 12 Weeks
Population: All patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost | Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment | 6.6 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 12
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost | Physician Assessment of Patient Compliance Compared to Previous Therapy | Better | 875 Patients |
| Bimatoprost | Physician Assessment of Patient Compliance Compared to Previous Therapy | Equal | 1151 Patients |
| Bimatoprost | Physician Assessment of Patient Compliance Compared to Previous Therapy | Worse | 51 Patients |
| Bimatoprost | Physician Assessment of Patient Compliance Compared to Previous Therapy | Not Applicable | 36 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 12
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost | Physician Assessment of Tolerability on a 4-Point Scale | Very Good | 1212 Patients |
| Bimatoprost | Physician Assessment of Tolerability on a 4-Point Scale | Good | 1059 Patients |
| Bimatoprost | Physician Assessment of Tolerability on a 4-Point Scale | Moderate | 74 Patients |
| Bimatoprost | Physician Assessment of Tolerability on a 4-Point Scale | Poor | 24 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 12
Population: All patients with data for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost | Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP lower than target | 622 Eyes |
| Bimatoprost | Physician Evaluation of IOP Lowering in the Study Eye(s) | Target IOP reached | 1173 Eyes |
| Bimatoprost | Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP decreased but target not reached | 467 Eyes |
| Bimatoprost | Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP increased | 85 Eyes |
| Bimatoprost | Physician Evaluation of IOP Lowering in the Study Eye(s) | No change | 119 Eyes |
| Bimatoprost | Physician Evaluation of IOP Lowering in the Study Eye(s) | Data Missing | 205 Eyes |