A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy With Carbachol Topical Ophthalmic Solution in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
研究概览
简要总结
Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
详细描述
A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy with Carbachol Topical Ophthalmic Solution in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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™
A single drop in each eye at a visit.
干预措施: BRIMOCHOL™ (Drug)
BRIMOCHOL™ F
A single drop in each eye at a visit.
干预措施: BRIMOCHOL™ F (Drug)
Carbachol
A single drop in each eye at a visit.
干预措施: Carbachol (Drug)
结局指标
主要结局
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
时间窗: Day 1, Hour 1 post-dose
Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
次要结局
- Change From Baseline ETDRS Letters Score in Distance Visual Acuity(Day 1, Hour 1 post-dose)