Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.
Interventions
DRUGAny Fixed Combination Therapy
Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy. This was a retrospective chart review study, so no treatment was administered in this study.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of glaucoma or ocular hypertension * Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | Baseline, 12 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 | 12 Weeks | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. |
| Physician Assessment of Tolerability Using a 4-Point Scale | 12 Weeks | Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. |
| Percentage of Patients Who Maintained Better Compliance With Treatment | 12 Weeks | Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance). |
| Percentage of Patients Continuing on Therapy After 12 Weeks | 12 Weeks | Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| POAG or OHT Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy | 4,385 |
| Total | 4,385 |
Baseline characteristics
| Characteristic | POAG or OHT |
|---|---|
| Age Continuous Data Available (N=2234) | 66.69 Years STANDARD_DEVIATION 11.43 |
| Age Continuous Missing Data (N=2151) | NA Years |
| Sex/Gender, Customized Female | 1177 Participants |
| Sex/Gender, Customized Male | 1111 Participants |
| Sex/Gender, Customized Missing Data | 2097 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4,385 |
| serious Total, serious adverse events | 4 / 4,385 |
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, 12 Weeks
Population: All patients who met the study entry criteria and have data for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Baseline - Right Eye (N=2286) | 21.72 Millimeters of Mercury (mmHg) | Standard Deviation 3.62 |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at 12 Wks-Rt Eye (N=2235) | -4.93 Millimeters of Mercury (mmHg) | Standard Deviation 3.24 |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Baseline - Left Eye (N=2248) | 21.59 Millimeters of Mercury (mmHg) | Standard Deviation 3.61 |
| POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at 12 Wks-Lft Eye (N=2192) | -4.88 Millimeters of Mercury (mmHg) | Standard Deviation 3.27 |
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 percentage of patients assessed as good and very good combined are reported.
Time frame: 12 Weeks
Population: All patients who met the study entry criteria and have data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Patient Assessment of Tolerability Using a 4-Point Scale | 79.2 Percentage of Patients |
Secondary
Percentage of Patients Continuing on Therapy After 12 Weeks
Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.
Time frame: 12 Weeks
Population: All patients who met the study entry criteria and have data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Percentage of Patients Continuing on Therapy After 12 Weeks | 92.9 Percentage of Patients |
Secondary
Percentage of Patients Who Maintained Better Compliance With Treatment
Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).
Time frame: 12 Weeks
Population: All patients who met the study entry criteria and have data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Percentage of Patients Who Maintained Better Compliance With Treatment | 33.5 Percentage of Patients |
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 percentage of patients assessed as good and very good combined are reported.
Time frame: 12 Weeks
Population: All patients who met the study entry criteria and have data for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Physician Assessment of Tolerability Using a 4-Point Scale | 87.6 Percentage of Patients |