A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

Completed

• Conditions: Glaucoma, Primary Open Angle; Ocular Hypertension
• Interventions: Drug: Bimatoprost Ophthalmic Solution

• Registration Number: NCT01853085
• Lead Sponsor: Allergan

Brief Summary

The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-01
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-14
• Primary Completion: 2014-03-01
• Study Completion: 2014-03-01
• Results First Submitted: 2015-05-12
• Results First Submitted QC: 2015-05-12
• Results First Posted: 2015-05-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1830

Inclusion Criteria

• Diagnosed with primary open-angle glaucoma or ocular hypertension
• Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

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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
Patients with POAG or OHT	Bimatoprost Ophthalmic Solution	Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.

Primary Outcome Measures

Name	Time	Method
IOP in the Study Eye at Week 12	Week 12	IOP is a measurement of the fluid pressure inside the study eye.
Intraocular Pressure (IOP) in the Study Eye at Baseline	Baseline	IOP is a measurement of the fluid pressure inside the study eye.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment	12 Weeks	Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.
Physician Assessment of Tolerability on a 4-Point Scale	12 Weeks	Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale	Baseline, 12 Weeks	IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale	12 Weeks	Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.
Patient Assessment of Tolerability on a 4-Point Scale	12 Weeks	Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Number of Patients Who Continue Treatment	12 Weeks	Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.