A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Study Overview
=================
Brief Summary
-----------------
A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.01% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of POAG or OHT Prescribed Lumigan® 0.01% Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumigan® 0.01%<br>Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks. | Drug: bimatoprost 0.01% ophthalmic solution<br>* Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.<br>* Other names: Lumigan® 0.01%;|

What is the study measuring?
-----------------
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 14 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14. | Week 14 | 

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 14 | 
| 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 14 | 
| 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 14 | 
| Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment | Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No. | 14 Weeks | 
| Percentage of Patients Who Continue Lumigan® 0.01% Treatment | Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No. | Week 14 | 
| 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 14 |