Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
Interventions
Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary open angle glaucoma or ocular hypertension * Prescribed Lumigan®
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | Baseline, 14 Weeks | IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Tolerability Using a 4-Point Scale | 14 Weeks | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. |
| Physician Assessment of Tolerability Using a 4-Point Scale | 14 Weeks | Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. |
| Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks | 14 Weeks | Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No. |
| Patients Who Will Continue Use of Lumigan® After 14 Weeks | 14 Weeks | Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| POAG or OHT Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry | 854 |
| Total | 854 |
Baseline characteristics
| Characteristic | POAG or OHT |
|---|---|
| Age Continuous | 66.75 Years STANDARD_DEVIATION 13.27 |
| Sex/Gender, Customized Female | 458 Participants |
| Sex/Gender, Customized Male | 394 Participants |
| Sex/Gender, Customized Missing Data | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 854 |
| serious Total, serious adverse events | 0 / 854 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.
Time frame: Baseline, 14 Weeks
Population: All enrolled patients with complete data for this outcome measure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Baseline - Right Eye (N=830) | 19.0 Millimeters of Mercury (mmHg) |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at 14 Wks-Rt Eye (N=830) | -4.0 Millimeters of Mercury (mmHg) |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Baseline - Left Eye (N=836) | 20.0 Millimeters of Mercury (mmHg) |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at 14 Wks-Lft Eye (N=836) | -5.0 Millimeters of Mercury (mmHg) |
Secondary
Patient Assessment of Tolerability Using a 4-Point Scale
Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.
Time frame: 14 Weeks
Population: All enrolled patients with complete data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Patient Assessment of Tolerability Using a 4-Point Scale | 755 Participants |
Secondary
Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks
Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.
Time frame: 14 Weeks
Population: All enrolled patients with complete data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks | 70 Participants |
Secondary
Patients Who Will Continue Use of Lumigan® After 14 Weeks
Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.
Time frame: 14 Weeks
Population: All enrolled patients with complete data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Patients Who Will Continue Use of Lumigan® After 14 Weeks | 723 Participants |
Secondary
Physician Assessment of Tolerability Using a 4-Point Scale
Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.
Time frame: 14 Weeks
Population: All enrolled patients with complete data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Physician Assessment of Tolerability Using a 4-Point Scale | 788 Participants |