NCT06609525招募中2 期
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferior, Phase Ⅱb/Ⅲ Study to Evaluate the Safety and Efficacy of CTO0303
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- pupillary dilation effect at 30 minutes after administration
研究概览
简要总结
This is a prospective randomized study compared with active control arm.
详细描述
This is a prospective randomized study compared with active control arm. The investigators compare the pupil size in subject when 30 minutes after administering IP (CTO0303 or active control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric or adolescent subjects those who get a written consent both whom and their parents (or legally acceptable representative)
- •Pediatric or adolescent subjects aged 4 to 15 years old based on date of written consent
排除标准
- •Subjects with a history of severe systemic reaction or increased sensitivity to atropine
- •Subjects with anterior segment disease that interferes with ophthalmological examination (ex. corneal scar, corneal opacity and others)
- •Subjects administered mydriatic medication within 14 days prior to administration of Investigational Product
- •Subjects with contact lens
研究组 & 干预措施
CTO0303-A
Experimental
干预措施: CTO0303-A (Drug)
CTO0303-B
Experimental
干预措施: CTO0303-B (Drug)
CTO0303-C
Active Comparator
干预措施: CTO0303-C (Drug)
结局指标
主要结局
pupillary dilation effect at 30 minutes after administration
时间窗: From enrollment to the end of treatment at 1 day.
The pupil size is measured using a pupillometer 30 minutes after IP administration
次要结局
未报告次要终点
研究者
研究点 (1)
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