A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops in Slowing the Progression of Myopia in Children
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 777
- 试验地点
- 1
- 主要终点
- Cycloplegic Autorefraction(SER)
研究概览
简要总结
A randomized, double-blind, placebo-controlled, multicenter, phase III clinical study of the efficacy and safety of two low-concentration atropine sulfate eye drops in slowing the progression of myopia in children
详细描述
Primary objective is to evaluate the efficacy and safety of atropine sulfate eye drops versus placebo for 12 months in slowing the progression of myopia in children.
The study was designed to enroll approximately 777 subjects. Eligible subjects were randomly assigned to the placebo control group, Lower dose atropine group and Lower dose atropine group. Subjects received the study medication in both eyes, 1 drop each time, once every night at bedtime.
Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child (female or male) aged 6 to 12 years.
- •Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby cycloplegic autorefraction.
- •If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.
- •Anisometropia SER of < 1.50 D as measured by cycloplegic autorefraction.
排除标准
- •Have used other myopia control methods other than those used in this study, such as instruments (orthokeratology lenses, multifocal glasses, progressive glasses), drugs (atropine, etc.); Only single vision glasses are allowed for myopia correction;
- •Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;
- •Use of any local or systemic antimuscarinic/anticholinergic medication (e.g., atropine, scopolamine, tropicamide, phenamine, diphenhydramine, oxytropine, tricyclic antidepressant, etc.) within 21 days before screening; Allowing for tests such as cycloplegic optometry;
研究组 & 干预措施
Experimental group 1
Lower dose atropine sulfate eye drops
干预措施: Lower dose atropine sulfate eye drops (Drug)
Experimental group 2
Low dose atropine sulfate eye drops
干预措施: Low dose atropine sulfate eye drops (Drug)
control group
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Cycloplegic Autorefraction(SER)
时间窗: 24 months
Between-group difference in the mean change from baseline in SER at visit M24
次要结局
- Axial Length(24 months)