An observational study in Glaucoma, Primary Open Angle and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2019-04-19.
Sponsored by Allergan · Observational
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 1,553 is above the median of 103 across 454 observational studies indexed under Glaucoma.
Browse Glaucoma studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
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Counted across the registry records on this site, refreshed daily.
Patients with primary open-angle glaucoma or ocular hypertension
Exclusion Criteria:
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.
Drug: Fixed 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.
Also known as: GANFORT® UD
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)
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)
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)
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)
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
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)
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)
| Milestone | Patients With POAG or OHT |
|---|---|
| Started | 1553 |
| Completed | 1433 |
| Not completed | 120 |
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).
| mmHg | Patients With POAG or OHT |
|---|---|
| Baseline | 22.18 ± 3.55 |
| Final Visit | 16.11 ± 2.87 |
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.
| participants | Patients With POAG or OHT |
|---|---|
| Better than expected | 497 |
| As expected | 729 |
| Worse than expected | 98 |
| Missing data | 67 |
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.
| participants | Patients With POAG or OHT |
|---|---|
| Very good | 788 |
| Good | 461 |
| Moderate | 45 |
| Poor | 50 |
| Missing | 47 |
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.
| participants | Patients With POAG or OHT |
|---|---|
| Very good | 809 |
| Good | 474 |
| Moderate | 40 |
| Poor | 28 |
| Missing | 40 |
The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit
| percentage of participants | Patients With POAG or OHT |
|---|---|
| Percentage of Patients Who Discontinued Treatment | 6.47 |
The percentage of participants who continued treatment with Ganfort® UD after Week 12.
| percentage of participants | Patients With POAG or OHT |
|---|---|
| Percentage of Patients Prescribed by the Physician to Continue Treatment | 89.14 |
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.
| participants | Patients With POAG or OHT |
|---|---|
| Better | 727 |
| Equal | 542 |
| Worse | 34 |
| Missing | 49 |
Collected over Up to 12 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With POAG or OHT | — | 1/1,553 (0.1%) | 0/1,553 (0%) |
| Event | Patients With POAG or OHT |
|---|---|
| DeathGeneral disorders | 1/1553 |
| Age, Customized(participants) | Patients With POAG or OHT |
|---|---|
| Less than 18 years | 1 |
| 18 to 30 years | 8 |
| 31 to 40 years | 21 |
| 41 to 50 years | 119 |
| 51 to 60 years | 313 |
| 61 to 70 years | 415 |
| 71 to 80 years | 477 |
| 81 to 90 years | 155 |
| Greater than or equal to 91 | 8 |
| Missing data | 36 |
| Sex/Gender, Customized(participants) | Patients With POAG or OHT |
|---|---|
| Female | 913 |
| Male | 631 |
| Missing data | 9 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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