Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.
Interventions
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary open-angle glaucoma or ocular hypertension * Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy
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 eye at Baseline. |
| Intraocular Pressure (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 eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Evaluation of Tolerability of Treatment | Week 12 | The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported. |
| Physician Evaluation of Efficacy Using a 5-Point Scale | Week 12 | The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported. |
| Number of Patients Continuing Treatment After 12 Weeks | Week 12 | The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment? |
| Physician Reported Reasons for Early Discontinuation of Treatment | 12 Weeks | The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. |
| Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale | Week 12 | Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported. |
Countries
Switzerland
Participant flow
Pre-assignment details
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. There was no investigational drug administered in this study.
Participants by arm
| Arm | Count |
|---|---|
| Lumigan® 0.01% Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. | 387 |
| Total | 387 |
Baseline characteristics
| Characteristic | Lumigan® 0.01% |
|---|---|
| Age, Customized 18 to 30 Years | 1 Participants |
| Age, Customized 31 to 40 Years | 3 Participants |
| Age, Customized 41 to 50 Years | 28 Participants |
| Age, Customized 51 to 60 Years | 53 Participants |
| Age, Customized 61 to 70 Years | 113 Participants |
| Age, Customized 71 to 80 Years | 120 Participants |
| Age, Customized 81 to 90 Years | 62 Participants |
| Age, Customized >=91 Years | 5 Participants |
| Age, Customized Missing data | 2 Participants |
| Sex: Female, Male Female | 237 Participants |
| Sex: Female, Male Male | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 148 / 387 |
| serious Total, serious adverse events | 0 / 387 |
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 eye at Baseline.
Time frame: Baseline
Population: All participants with complete data available for IOP.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lumigan® 0.01% | Intraocular Pressure (IOP) at Baseline | Right Eye (n=334) | 22.0 mm Hg |
| Lumigan® 0.01% | Intraocular Pressure (IOP) at Baseline | Left Eye | 22.0 mm Hg |
Primary
Intraocular Pressure (IOP) at Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.
Time frame: Week 12
Population: All participants with complete data available for IOP.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lumigan® 0.01% | Intraocular Pressure (IOP) at Week 12 | Right Eye (n=334) | 16.0 mm Hg |
| Lumigan® 0.01% | Intraocular Pressure (IOP) at Week 12 | Left Eye | 16.0 mm Hg |
Secondary
Number of Patients Continuing Treatment After 12 Weeks
The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?
Time frame: Week 12
Population: All participants with data available for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumigan® 0.01% | Number of Patients Continuing Treatment After 12 Weeks | 302 Participants |
Secondary
Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale
Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.
Time frame: Week 12
Population: All participants with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumigan® 0.01% | Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale | Very good | 157 Participants |
| Lumigan® 0.01% | Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale | Good | 144 Participants |
| Lumigan® 0.01% | Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale | Moderate | 7 Participants |
| Lumigan® 0.01% | Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale | Poor | 16 Participants |
Secondary
Physician Evaluation of Efficacy Using a 5-Point Scale
The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.
Time frame: Week 12
Population: All participants with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumigan® 0.01% | Physician Evaluation of Efficacy Using a 5-Point Scale | IOP lower than target | 87 Participants |
| Lumigan® 0.01% | Physician Evaluation of Efficacy Using a 5-Point Scale | Target IOP reached | 187 Participants |
| Lumigan® 0.01% | Physician Evaluation of Efficacy Using a 5-Point Scale | IOP decreased but target not reached | 64 Participants |
| Lumigan® 0.01% | Physician Evaluation of Efficacy Using a 5-Point Scale | IOP increased | 6 Participants |
| Lumigan® 0.01% | Physician Evaluation of Efficacy Using a 5-Point Scale | No Change | 15 Participants |
Secondary
Physician Evaluation of Tolerability of Treatment
The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.
Time frame: Week 12
Population: All participants with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumigan® 0.01% | Physician Evaluation of Tolerability of Treatment | Very good | 174 Participants |
| Lumigan® 0.01% | Physician Evaluation of Tolerability of Treatment | Good | 141 Participants |
| Lumigan® 0.01% | Physician Evaluation of Tolerability of Treatment | Moderate | 12 Participants |
| Lumigan® 0.01% | Physician Evaluation of Tolerability of Treatment | Poor | 6 Participants |
Secondary
Physician Reported Reasons for Early Discontinuation of Treatment
The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.
Time frame: 12 Weeks
Population: All participants who discontinued treatment early.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lumigan® 0.01% | Physician Reported Reasons for Early Discontinuation of Treatment | Unacceptable ocular tolerability | 28 Participants |
| Lumigan® 0.01% | Physician Reported Reasons for Early Discontinuation of Treatment | Patient decision to withdraw from study | 21 Participants |
| Lumigan® 0.01% | Physician Reported Reasons for Early Discontinuation of Treatment | Insufficient IOP control | 18 Participants |
| Lumigan® 0.01% | Physician Reported Reasons for Early Discontinuation of Treatment | Physician decision to withdraw patient from study | 8 Participants |
| Lumigan® 0.01% | Physician Reported Reasons for Early Discontinuation of Treatment | Patient lost to follow up | 1 Participants |
| Lumigan® 0.01% | Physician Reported Reasons for Early Discontinuation of Treatment | Other reason | 6 Participants |
| Lumigan® 0.01% | Physician Reported Reasons for Early Discontinuation of Treatment | Missing data | 1 Participants |