Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This is an observational study and will evaluate IOP reduction in newly diagnosed patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Interventions
OTHERStandard of Care
Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed with primary open angle glaucoma or ocular hypertension
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline | Baseline, 14 Weeks | Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an IOP Reduction ≥10% From Baseline | Baseline, 14 Weeks | Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit. |
| Percentage of Patients With an IOP Reduction ≥20% From Baseline | Baseline, 14 Weeks | Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| POAG or OHT Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care. | 4,812 |
| Total | 4,812 |
Baseline characteristics
| Characteristic | POAG or OHT |
|---|---|
| Age Continuous Evaluable (N=2647 patients) | 64.72 Years STANDARD_DEVIATION 12.03 |
| Age Continuous Missing (N=2165 patients) | NA Years |
| Sex/Gender, Customized Female | 1642 Participants |
| Sex/Gender, Customized Male | 1389 Participants |
| Sex/Gender, Customized Missing | 1781 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 180 / 3,037 |
| serious Total, serious adverse events | 0 / 3,037 |
Outcome results
Primary
Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline
Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.
Time frame: Baseline, 14 Weeks
Population: Evaluable Patients: all patients who met the study entry criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline | 75.9 Millimeters of Mercury (mmHg) |
Secondary
Percentage of Patients With an IOP Reduction ≥10% From Baseline
Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit.
Time frame: Baseline, 14 Weeks
Population: Evaluable Patients: all patients who met the study entry criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Percentage of Patients With an IOP Reduction ≥10% From Baseline | 91.0 Percentage of Patients |
Secondary
Percentage of Patients With an IOP Reduction ≥20% From Baseline
Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit.
Time frame: Baseline, 14 Weeks
Population: Evaluable Patients: all patients who met the study entry criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POAG or OHT | Percentage of Patients With an IOP Reduction ≥20% From Baseline | 70.8 Percentage of Patients |