Safety and Efficacy of Combigan® Ophthalmic Solution in Korea

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution

• Registration Number: NCT01987752
• Lead Sponsor: Allergan

Brief Summary

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta blockers treated as per standard of care in clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-19
• Status Verified: 2014-02
• Results First Submitted: 2014-02-25
• Results First Submitted QC: 2014-02-25
• Last Update Submitted: 2014-02-25
• Results First Posted: 2014-04-04
• Last Update Posted: 2014-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 732

Inclusion Criteria

• Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution as standard of care in clinical practice.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combigan® Ophthalmic Solution	brimonidine tartrate/timolol maleate Ophthalmic Solution	Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Adverse Events	Up to 2.6 Years	An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)	Baseline, Week 4	IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.