Glaucoma, Primary Open Angle, Ocular Hypertension
Conditions
Brief summary
The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.
Interventions
DRUGFixed Combination Bimatoprost and Timolol
Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosed with primary open-angle glaucoma or ocular hypertension * Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline, Final Visit (Week 8 to 12) | IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Tolerability on a 4-Point Scale | Final Visit (Week 8 to 12) | The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. |
| Physician Assessment of Tolerability on a 4-Point Scale | Final Visit (Week 8 to 12) | The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported. |
| Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Baseline, Final Visit (Week 8 to 12) | The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported. |
| Percentage of Patients Prescribed by the Physician to Continue Treatment | Final Visit (Week 8 to 12) | The percentage of participants who continued treatment with Ganfort® UD after Week 12. |
| Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Final Visit (Week 8 to 12) | The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported. |
| Percentage of Patients Who Discontinued Treatment | 12 Weeks | The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With POAG or OHT Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks. | 1,553 |
| Total | 1,553 |
Baseline characteristics
| Characteristic | Patients With POAG or OHT |
|---|---|
| Age, Customized 18 to 30 years | 8 participants |
| Age, Customized 31 to 40 years | 21 participants |
| Age, Customized 41 to 50 years | 119 participants |
| Age, Customized 51 to 60 years | 313 participants |
| Age, Customized 61 to 70 years | 415 participants |
| Age, Customized 71 to 80 years | 477 participants |
| Age, Customized 81 to 90 years | 155 participants |
| Age, Customized Greater than or equal to 91 | 8 participants |
| Age, Customized Less than 18 years | 1 participants |
| Age, Customized Missing data | 36 participants |
| Sex/Gender, Customized Female | 913 participants |
| Sex/Gender, Customized Male | 631 participants |
| Sex/Gender, Customized Missing data | 9 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,553 |
| serious Total, serious adverse events | 1 / 1,553 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).
Time frame: Baseline, Final Visit (Week 8 to 12)
Population: Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline | 22.18 mmHg | Standard Deviation 3.55 |
| Patients With POAG or OHT | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Final Visit | 16.11 mmHg | Standard Deviation 2.87 |
Secondary
Patient Assessment of Tolerability on a 4-Point Scale
The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.
Time frame: Final Visit (Week 8 to 12)
Population: Per-protocol population included all treated participants who had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Moderate | 45 participants |
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Poor | 50 participants |
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Missing | 47 participants |
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Very good | 788 participants |
| Patients With POAG or OHT | Patient Assessment of Tolerability on a 4-Point Scale | Good | 461 participants |
Secondary
Percentage of Patients Prescribed by the Physician to Continue Treatment
The percentage of participants who continued treatment with Ganfort® UD after Week 12.
Time frame: Final Visit (Week 8 to 12)
Population: Per-protocol population included all treated participants who had no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With POAG or OHT | Percentage of Patients Prescribed by the Physician to Continue Treatment | 89.14 percentage of participants |
Secondary
Percentage of Patients Who Discontinued Treatment
The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit
Time frame: 12 Weeks
Population: Per-protocol population included all treated participants who had no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With POAG or OHT | Percentage of Patients Who Discontinued Treatment | 6.47 percentage of participants |
Secondary
Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale
The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.
Time frame: Baseline, Final Visit (Week 8 to 12)
Population: Per-protocol population included all treated participants who had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Better than expected | 497 participants |
| Patients With POAG or OHT | Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | As expected | 729 participants |
| Patients With POAG or OHT | Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Worse than expected | 98 participants |
| Patients With POAG or OHT | Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale | Missing data | 67 participants |
Secondary
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.
Time frame: Final Visit (Week 8 to 12)
Population: All participants from the Per-protocol population, all treated participants who had no major protocol violations, who received previous treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Better | 727 participants |
| Patients With POAG or OHT | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Equal | 542 participants |
| Patients With POAG or OHT | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Worse | 34 participants |
| Patients With POAG or OHT | Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Missing | 49 participants |
Secondary
Physician Assessment of Tolerability on a 4-Point Scale
The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.
Time frame: Final Visit (Week 8 to 12)
Population: Per-protocol population included all treated participants who had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Very good | 809 participants |
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Poor | 28 participants |
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Missing | 40 participants |
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Good | 474 participants |
| Patients With POAG or OHT | Physician Assessment of Tolerability on a 4-Point Scale | Moderate | 40 participants |