Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Completed

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

• Registration Number: NCT01489670
• Lead Sponsor: Allergan

Brief Summary

This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-02
• Results First Submitted: 2014-02-13
• Results First Submitted QC: 2014-02-13
• Last Update Submitted: 2014-02-13
• Results First Posted: 2014-03-28
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

• Diagnosis of primary open-angle glaucoma or ocular hypertension
• Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy

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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
Lumigan® 0.01%	bimatoprost 0.01% ophthalmic solution	Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.

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 and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.

Secondary Outcome Measures

Name	Time	Method
Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale	Week 12	Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.
Physician Evaluation of Tolerability of Treatment	Week 12	The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.
Physician Reported Reasons for Early Discontinuation of Treatment	12 Weeks	The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.
Physician Evaluation of Efficacy Using a 5-Point Scale	Week 12	The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.
Number of Patients Continuing Treatment After 12 Weeks	Week 12	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?