A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Completed

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

• Registration Number: NCT01589510
• Lead Sponsor: Allergan

Brief Summary

A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-01-21
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Results First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

Inclusion Criteria

• Diagnosis of POAG or OHT
• Prescribed Lumigan® 0.01%

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumigan® 0.01%	bimatoprost 0.01% ophthalmic solution	Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) at Baseline	Baseline	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.
IOP at Week 14	Week 14	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.

Secondary Outcome Measures

Name	Time	Method
Physician Evaluation of IOP Lowering in the Study Eye(s)	Week 14	IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.
Patient Assessment of Tolerability on a 4-Point Scale	Week 14	Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Physician Assessment of Tolerability on a 4-Point Scale	Week 14	Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment	14 Weeks	Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.
Percentage of Patients Who Continue Lumigan® 0.01% Treatment	Week 14	Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.
Physician Assessment of Patient Compliance Compared to Previous Therapy	Week 14	Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.