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

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.

Completed

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None.

Treatment and study plan

bimatoprost/timolol

Drug

Bimatoprost/timolol (Ganfort®) treatment for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.

Other names: Ganfort®

Primary outcomes

Number of Participants With Adverse Events and Adverse Drug Reactions

Time frame: 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 outcomes

Change From Baseline in Intraocular Pressure (IOP)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Nov 6, 2013
Registry last updated: Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed