Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 661
- 主要终点
- Clinical Effectiveness Rate
研究概览
简要总结
The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
详细描述
All the patients whom an investigator prescribes the first Xalacom® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 need to be administered Xalacom® in order to be enrolled in the surveillance.
排除标准
- •Patients not administered Xalacom®.
研究组 & 干预措施
Latan-timolol maleate fixed comb ophthalmic solution
干预措施: Latanoprost-timolol maleate fixed combination ophthalmic solution (Drug)
结局指标
主要结局
Clinical Effectiveness Rate
时间窗: Max 104 weeks
Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks).
Number of Participants WithTreatment-Related Adverse Events
时间窗: Max 104 weeks
A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator.
次要结局
未报告次要终点