A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Conditions
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Glaucoma, 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 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost 0.01% (Naive Monotherapy)<br>1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. | Drug: Bimatoprost 0.01%<br>* 1 drop in the affected eye(s), administered in the evening for 12 weeks.<br>* Other names: LUMIGAN® 0.01%;|
| Experimental: Bimatoprost 0.01% (Switched Monotherapy)<br>1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. | Drug: Bimatoprost 0.01%<br>* 1 drop in the affected eye(s), administered in the evening for 12 weeks.<br>* Other names: LUMIGAN® 0.01%;|
| Experimental: Bimatoprost 0.01% (with Adjunctive Therapy)<br>1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. | Drug: Bimatoprost 0.01%<br>* 1 drop in the affected eye(s), administered in the evening for 12 weeks.<br>* Other names: LUMIGAN® 0.01%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Week 6, Week 12 | 
| Overall Percent Change From Baseline in IOP | IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement). | Baseline, Week 6, Week 12 |