A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting

Study Overview
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Brief Summary
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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.

Conditions
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Glaucoma, Primary Open Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Fixed Combination Bimatoprost and Timolol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with POAG or OHT<br>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<br>* 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.<br>* Other names: GANFORT® UD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, Final Visit (Week 8 to 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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. | 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. | Final Visit (Week 8 to 12) |