Safety and Efficacy of Combigan® Ophthalmic Solution in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 732
- 主要终点
- Percentage of Participants Reporting Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution as standard of care in clinical practice.
排除标准
- 未提供
研究组 & 干预措施
Combigan® Ophthalmic Solution
Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
干预措施: brimonidine tartrate/timolol maleate Ophthalmic Solution (Drug)
结局指标
主要结局
Percentage of Participants Reporting Adverse Events
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点