A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

Phase 4

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: 0.03% Bimatoprost

• Registration Number: NCT02020512
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Status Verified: 2014-06
• Results First Submitted: 2014-06-24
• Results First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Results First Posted: 2014-07-21
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Diagnosis of open-angle glaucoma or ocular hypertension
• No use of Lumigan® in the past 3 months

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Exclusion Criteria

• Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.03% Bimatoprost	0.03% Bimatoprost	0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye	Baseline, Week 5	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).