Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: bimatoprost 0.01% ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of primary open-angle glaucoma or ocular hypertension Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Lumigan® 0.01%<br>Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. | Drug: bimatoprost 0.01% ophthalmic solution<br>* Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.<br>* Other names: Lumigan® 0.01%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) at Baseline | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline. | Baseline | 
| Intraocular Pressure (IOP) at Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Evaluation of Efficacy Using a 5-Point Scale | The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported. | Week 12 | 
| Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale | Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported. | Week 12 | 
| Physician Evaluation of Tolerability of Treatment | The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported. | Week 12 | 
| Physician Reported Reasons for Early Discontinuation of Treatment | The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient. | 12 Weeks | 
| Number of Patients Continuing Treatment After 12 Weeks | The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment? | Week 12 |