A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension

Phase 4

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Interventions: Drug: 0.15% Brimonidine Tartrate

• Registration Number: NCT02003534
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• 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: 2014-07-22
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

• Diagnosis of open-angle glaucoma or ocular hypertension

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Exclusion Criteria

• Used Alphagan® in previous 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.15% Brimonidine Tartrate	0.15% Brimonidine Tartrate	0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye	Baseline, Month 3	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).