A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

Study Overview
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Brief Summary
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The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy 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: Bimatoprost Ophthalmic Solution


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 Lumigan® 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 primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks. | Drug: Bimatoprost Ophthalmic Solution<br>* Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.<br>* Other names: Lumigan® UD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) in the Study Eye at Baseline | IOP is a measurement of the fluid pressure inside the study eye. | Baseline | 
| IOP in the Study Eye at Week 12 | IOP is a measurement of the fluid pressure inside the study eye. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale | IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented. | Baseline, 12 Weeks | 
| Patient Assessment of Tolerability on a 4-Point Scale | Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. | 12 Weeks | 
| Physician Assessment of Tolerability on a 4-Point Scale | Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. | 12 Weeks | 
| Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment | Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No. | 12 Weeks | 
| Number of Patients Who Continue Treatment | Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No. | 12 Weeks | 
| Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale | Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented. | 12 Weeks |