A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of POAG or OHT Previous use of IOP-lowering medication 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 |
| --- | --- |
| Bimatoprost<br>Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks. | Drug: Bimatoprost<br>* Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.<br>* Other names: GANFORT®;|

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 eyes at Baseline. | Baseline | 
| IOP at Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Evaluation of IOP Lowering in the Study Eye(s) | IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented. | Week 12 | 
| Patient Assessment of Tolerability on a 4-Point Scale | Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. | Week 12 | 
| Physician Assessment of Tolerability on a 4-Point Scale | Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented. | Week 12 | 
| Physician Assessment of Patient Compliance Compared to Previous Therapy | Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented. | Week 12 | 
| Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment | Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No. | 12 Weeks | 
| Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops | Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No. | Week 12 |