A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Completed

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

• Registration Number: NCT01632423
• Lead Sponsor: Allergan

Brief Summary

This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-03
• Status Verified: 2012-08
• Results First Submitted: 2012-08-21
• Results First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Results First Posted: 2012-09-21
• Last Update Posted: 2012-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10337

Inclusion Criteria

• Diagnosed with primary open angle glaucoma or ocular hypertension
• Prescribed Lumigan®

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POAG or OHT	bimatoprost 0.01%	Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP)	Baseline, 14 Weeks	IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Tolerability Using a 4-Point Scale	14 Weeks	Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.
Physician Assessment of Tolerability Using a 4-Point Scale	14 Weeks	Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.
Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks	14 Weeks	Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.
Patients Who Will Continue Use of Lumigan® After 14 Weeks	14 Weeks	Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.