NCT05135286已完成3 期
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
Visus Therapeutics1 个研究点 分布在 1 个国家目标入组 629 人开始时间: 2022年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 629
- 试验地点
- 1
- 主要终点
- Change from baseline in near VA
研究概览
简要总结
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
详细描述
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female in good general health
- •Must have presbyopia
排除标准
- •History of allergic reaction to the study drug or any of its components
- •Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results
研究组 & 干预措施
BRIMOCHOL™ PF
Experimental
A single drop in each eye at a visit.
干预措施: BRIMOCHOL™ PF (Drug)
Carbachol PF
Active Comparator
A single drop in each eye at a visit.
干预措施: Carbachol PF (Drug)
Vehicle
Placebo Comparator
A single drop in each eye at a visit.
干预措施: Vehicle (Drug)
结局指标
主要结局
Change from baseline in near VA
时间窗: Baseline Day 1
Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA
次要结局
未报告次要终点
研究者
研究点 (1)
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