Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their physician.
Interventions
DRUGFixed combination 0.3 mg bimatoprost and 5 mg timolol
Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary open angle glaucoma or ocular hypertension * Prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol)
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | Baseline, 18 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 |
|---|---|---|
| Physician Assessment of Tolerability Using a 4-Point Scale | 18 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. |
| Patient Assessment of Tolerability Using a 4-Point Scale | 18 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 Adherence to GANfort® | 18 Weeks | Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as better compliance are reported. |
| Patients Continuing With GANfort® After 18 Weeks | 18 Weeks | Patients continuing with GANfort® after 18 weeks was assessed as Yes or No. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| POAG or OHT Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry | 392 |
| Total | 392 |
Baseline characteristics
| Characteristic | POAG or OHT |
|---|---|
| Age Continuous | 67.22 Years STANDARD_DEVIATION 13.14 |
| Sex/Gender, Customized Female | 232 Participants |
| Sex/Gender, Customized Male | 155 Participants |
| Sex/Gender, Customized Missing Data | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 392 |
| serious Total, serious adverse events | 1 / 392 |
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, 18 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=345) | 22.0 Millimeters of Mercury (mmHg) |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at 18 Wks-Rt Eye (N=345) | -6.0 Millimeters of Mercury (mmHg) |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Baseline - Left Eye (N=344) | 22.0 Millimeters of Mercury (mmHg) |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at 18 Wks-Lft Eye (N=344) | -6.0 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: 18 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 | 319 Participants |
Secondary
Patients Continuing With GANfort® After 18 Weeks
Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.
Time frame: 18 Weeks
Population: All enrolled patients with complete data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Patients Continuing With GANfort® After 18 Weeks | 329 Participants |
Secondary
Physician Assessment of Adherence to GANfort®
Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as better compliance are reported.
Time frame: 18 Weeks
Population: All enrolled patients with complete data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Physician Assessment of Adherence to GANfort® | 112 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: 18 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 | 340 Participants |