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

Phase 4

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Interventions: Drug: Bimatoprost 0.01%

• Registration Number: NCT01594970
• Lead Sponsor: Allergan

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-01
• Results First Submitted: 2014-01-27
• Results First Submitted QC: 2014-01-27
• Last Update Submitted: 2014-01-27
• Results First Posted: 2014-01-28
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bimatoprost 0.01% (with Adjunctive Therapy)	Bimatoprost 0.01%	1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Bimatoprost 0.01% (Naive Monotherapy)	Bimatoprost 0.01%	1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
Bimatoprost 0.01% (Switched Monotherapy)	Bimatoprost 0.01%	1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale	Week 12	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.

Secondary Outcome Measures

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