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

Phase 4

Completed

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

• Registration Number: NCT02061683
• Lead Sponsor: Allergan

Brief Summary

This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-19
• Primary Completion: 2011-06-24
• Study Completion: 2011-06-24
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Results First Submitted: 2014-05-19
• Results First Submitted QC: 2014-05-19
• Results First Posted: 2014-06-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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
Bimatoprost 0.03%	Bimatoprost 0.03%	Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) in the Study Eye	Month 3	IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog \[PGA\] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With an Adverse Event of Conjunctival Hyperemia	3 Months	Conjunctival 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). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.