Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.
Interventions
Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT) * Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Right Eye | Baseline, Week 12 | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. |
| Change From Baseline in Intraocular Pressure (IOP) in the Left Eye | Baseline, Week 12 | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks | 12 Weeks | — |
| Percentage of Participants Who Continue the New Treatment After 12 Weeks | 12 Weeks | — |
| Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale | 12 Weeks | The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported. |
| Physician Assessment of Efficacy Using a 5-Point Scale | 12 Weeks | The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported. |
| Percentage of Participants Reaching Individual IOP Target After 12 Weeks | 12 Weeks | — |
| Physician Assessment of Adherence to New Treatment Using a 4-Point Scale | 12 Weeks | The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported. |
| Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale | 12 Weeks | The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With POAG or OHT Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice. | 358 |
| Total | 358 |
Baseline characteristics
| Characteristic | Patients With POAG or OHT |
|---|---|
| Age, Customized 18 to 30 years | 10 participants |
| Age, Customized 31 to 40 years | 9 participants |
| Age, Customized 41 to 50 years | 28 participants |
| Age, Customized 51 to 60 years | 89 participants |
| Age, Customized 61 to 70 years | 125 participants |
| Age, Customized 71 to 80 years | 81 participants |
| Age, Customized 81 to 90 years | 16 participants |
| Sex: Female, Male Female | 180 Participants |
| Sex: Female, Male Male | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 358 |
| serious Total, serious adverse events | 0 / 358 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP) in the Left Eye
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Time frame: Baseline, Week 12
Population: All participant with IOP data at Baseline and Week 12 for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) in the Left Eye | -4.2 mmHg | Standard Deviation 5 |
Primary
Change From Baseline in Intraocular Pressure (IOP) in the Right Eye
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
Time frame: Baseline, Week 12
Population: All participant with IOP data at Baseline and Week 12 for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) in the Right Eye | -4.5 mmHg | Standard Deviation 4.6 |
Secondary
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale
The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.
Time frame: 12 Weeks
Population: All participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale | Very good | 48.6 percentage of participants |
| Patients With POAG or OHT | Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale | Good | 31.6 percentage of participants |
| Patients With POAG or OHT | Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale | Moderate | 6.1 percentage of participants |
| Patients With POAG or OHT | Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale | Poor | 1.7 percentage of participants |
| Patients With POAG or OHT | Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale | Missing data | 12.0 percentage of participants |
Secondary
Percentage of Participants Reaching Individual IOP Target After 12 Weeks
Time frame: 12 Weeks
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With POAG or OHT | Percentage of Participants Reaching Individual IOP Target After 12 Weeks | 49.7 percentage of participants |
Secondary
Percentage of Participants Who Continue the New Treatment After 12 Weeks
Time frame: 12 Weeks
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With POAG or OHT | Percentage of Participants Who Continue the New Treatment After 12 Weeks | 83.5 percentage of participants |
Secondary
Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks
Time frame: 12 Weeks
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With POAG or OHT | Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks | 7.5 percentage of participants |
Secondary
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale
The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.
Time frame: 12 Weeks
Population: All Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of Adherence to New Treatment Using a 4-Point Scale | Not Applicable | 1.68 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Adherence to New Treatment Using a 4-Point Scale | Worse | 4.47 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Adherence to New Treatment Using a 4-Point Scale | Equal | 42.74 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Adherence to New Treatment Using a 4-Point Scale | Better | 41.34 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Adherence to New Treatment Using a 4-Point Scale | Missing data | 9.78 percentage of participants |
Secondary
Physician Assessment of Efficacy Using a 5-Point Scale
The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.
Time frame: 12 Weeks
Population: All participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of Efficacy Using a 5-Point Scale | Missing data | 9.8 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Efficacy Using a 5-Point Scale | IOP lower than target | 24.0 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Efficacy Using a 5-Point Scale | Reached target IOP | 49.7 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Efficacy Using a 5-Point Scale | IOP decreased but target NOT reached | 10.9 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Efficacy Using a 5-Point Scale | No change | 0.8 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Efficacy Using a 5-Point Scale | IOP increased | 4.7 percentage of participants |
Secondary
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale
The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.
Time frame: 12 Weeks
Population: All participants with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale | Very good | 50.0 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale | Good | 33.0 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale | Moderate | 4.7 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale | Poor | 2.2 percentage of participants |
| Patients With POAG or OHT | Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale | Missing data | 10.1 percentage of participants |