Open-Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.
Interventions
Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.
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 POAG or OHT * Prescribed Lumigan® 0.01%
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 eye and the right eye at Week 12. The lower the IOP values the greater the improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Treatment Tolerability Using a 4-Point Scale | 12 weeks | Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported. |
| Physician Assessment of Treatment Tolerability Using a 4-Point Scale | 12 weeks | The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported. |
| Physician Reported Reasons for Treatment Discontinuation | 12 weeks | The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. |
| Number of Patients Continuing Treatment After 12 Weeks | 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? |
Countries
Belgium
Participant flow
Pre-assignment details
This was an observational study of participants who received Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) at a dose and frequency as determined by the physician prior to entry into the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician. | 933 |
| Total | 933 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 65.40 Years STANDARD_DEVIATION 11.88 |
| Sex/Gender, Customized Female | 480 Participants |
| Sex/Gender, Customized Male | 442 Participants |
| Sex/Gender, Customized Missing data | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 933 |
| serious Total, serious adverse events | 7 / 933 |
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 patients with complete data available for IOP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Intraocular Pressure (IOP) at Baseline | Right Eye (n=885) | 22.04 mm Hg | Standard Deviation 5.17 |
| All Participants | Intraocular Pressure (IOP) at Baseline | Left Eye | 22.07 mm Hg | Standard Deviation 5.12 |
Primary
Intraocular Pressure (IOP) at Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.
Time frame: Week 12
Population: All patients with complete data available for IOP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Intraocular Pressure (IOP) at Week 12 | Right Eye (n=885) | 16.94 mm Hg | Standard Deviation 3.88 |
| All Participants | Intraocular Pressure (IOP) at Week 12 | Left Eye | 17.02 mm Hg | Standard Deviation 4.15 |
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: 12 weeks
Population: All patients with data available for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Patients Continuing Treatment After 12 Weeks | 755 Participants |
Secondary
Patient Assessment of Treatment Tolerability 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 patients assessed in each of the categories is reported.
Time frame: 12 weeks
Population: All patients with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Patient Assessment of Treatment Tolerability Using a 4-Point Scale | Very good | 460 Participants |
| All Participants | Patient Assessment of Treatment Tolerability Using a 4-Point Scale | Good | 317 Participants |
| All Participants | Patient Assessment of Treatment Tolerability Using a 4-Point Scale | Moderate | 61 Participants |
| All Participants | Patient Assessment of Treatment Tolerability Using a 4-Point Scale | Poor | 50 Participants |
Secondary
Physician Assessment of Treatment Tolerability Using a 4-Point Scale
The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.
Time frame: 12 weeks
Population: All patients with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Physician Assessment of Treatment Tolerability Using a 4-Point Scale | Very good | 489 Participants |
| All Participants | Physician Assessment of Treatment Tolerability Using a 4-Point Scale | Good | 331 Participants |
| All Participants | Physician Assessment of Treatment Tolerability Using a 4-Point Scale | Moderate | 49 Participants |
| All Participants | Physician Assessment of Treatment Tolerability Using a 4-Point Scale | Poor | 24 Participants |
Secondary
Physician Reported Reasons for Treatment Discontinuation
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 patients with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Physician Reported Reasons for Treatment Discontinuation | Unacceptable ocular tolerability | 46 Participants |
| All Participants | Physician Reported Reasons for Treatment Discontinuation | Insufficient IOP control | 20 Participants |
| All Participants | Physician Reported Reasons for Treatment Discontinuation | Patient lost to follow up | 11 Participants |
| All Participants | Physician Reported Reasons for Treatment Discontinuation | Patient decision to withdraw from study | 8 Participants |
| All Participants | Physician Reported Reasons for Treatment Discontinuation | Physician decision to withdraw patient from study | 6 Participants |
| All Participants | Physician Reported Reasons for Treatment Discontinuation | Other reason | 6 Participants |