NCT05393895已完成3 期
A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events.
研究概览
简要总结
This is a multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will be treated for at least 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have presbyopia
排除标准
- •Have any contraindications to the study medications or diagnoses that would confound the study data
研究组 & 干预措施
CSF-1
Experimental
One drop bilaterally twice daily for at least 6 weeks
干预措施: CSF-1 (Drug)
Vehicle
Placebo Comparator
One drop bilaterally twice daily for at least 6 weeks
干预措施: Vehicle (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events.
时间窗: Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.
As this is a safety study, no efficacy outcome has been defined.
次要结局
未报告次要终点
研究者
研究点 (1)
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