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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Bimatoprost 0.01% ophthalmic solution

• Study Type: Observational
• Enrollment (Actual): 933

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with POAG or OHT

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.	Drug: Bimatoprost 0.01% ophthalmic solution; Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.; Other Names: Lumigan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP) at Baseline	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.	Baseline
Intraocular Pressure (IOP) at 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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment of Treatment Tolerability Using a 4-Point Scale	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.	12 weeks
Physician Assessment of Treatment Tolerability Using a 4-Point Scale	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.	12 weeks
Physician Reported Reasons for Treatment Discontinuation	The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.	12 weeks
Number of Patients Continuing Treatment After 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?	12 weeks

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: July 18, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Bimatoprost
• Other Study ID Numbers: MAF/AGN/OPH/GLA/031