Safety and Efficacy of Bimatoprost/Timolol (Ganfort®) Ophthalmic Solution in Korea

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: bimatoprost/timolol

• Registration Number: NCT01976624
• Lead Sponsor: Allergan

Brief Summary

This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular hypertension in Korea.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2015-06-22
• Results First Submitted QC: 2015-06-22
• Results First Posted: 2015-07-21
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-28
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

Inclusion Criteria

• Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension in clinical practice.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ganfort®	bimatoprost/timolol	Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events and Adverse Drug Reactions	Up to 51 months	An Adverse Event was considered 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. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP)	Baseline, Week 4	IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days.