Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Completed

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

• Registration Number: NCT01568008
• Lead Sponsor: Allergan

Brief Summary

This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-07
• Results First Submitted: 2013-07-18
• Results First Submitted QC: 2013-07-18
• Last Update Submitted: 2013-07-18
• Results First Posted: 2013-09-20
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 933

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
All participants	Bimatoprost 0.01% ophthalmic solution	Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.

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 eye at Baseline.
Intraocular Pressure (IOP) at Week 12	Week 12	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.

Secondary Outcome Measures

Name	Time	Method
Physician Assessment of Treatment Tolerability Using a 4-Point Scale	12 weeks	The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.
Physician Reported Reasons for Treatment Discontinuation	12 weeks	The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.
Number of Patients Continuing Treatment After 12 Weeks	12 weeks	The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?
Patient Assessment of Treatment Tolerability Using a 4-Point Scale	12 weeks	Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.