A Study of LUMIGAN® RC in the Clinical Setting

Study Overview
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Brief Summary
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This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.

Conditions
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Glaucoma, Primary Open Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost 0.01%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elevated IOP due to either primary open-angle glaucoma or ocular hypertension Determined by the treating physician to require treatment with LUMIGAN® RC 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost 0.01%<br>Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks. | Drug: Bimatoprost 0.01%<br>* Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.<br>* Other names: LUMIGAN® RC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Treatment-Naive Patients With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry. | Week 12 | 
| Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. | Week 12 | 
| Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients | IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, 12 Weeks | 
| Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, 12 Weeks | 
| Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, 12 Weeks | 
| Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients | IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, Week 6, Week 12 | 
| Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, Week 6, Week 12 | 
| Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, Week 6, Week 12 | 
| Percentage of Patients Discontinuing Due to Ocular Adverse Events | Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment. | 12 Weeks |