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
- 526
- 试验地点
- 1
- 主要终点
- Cycloplegic Autorefraction(low)
研究概览
简要总结
This study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase III clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children.
详细描述
Eligible subjects were screened and randomly assigned to the placebo control group, the lower dose group, and the lower dose group. Subjects received the study drug in both eyes, 1 drop each time, once every night before sleep, for continuous administration.A total of 526 subjects were planned to be enrolled。
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 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child (female or male) aged 6 to 10 years.
- •Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by 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
- •History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
- •History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia).
- •Chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year).
- •Use of cycloplegic drops for dilated ocular exam was allowable.
- •Heart rate persistently (for more than 10 minutes) > 120 beats per minute.
- •Allergy to study drugs.
研究组 & 干预措施
Experimental group 1
1 drop each time, once every night at bedtime
干预措施: Lower dose atropine sulfate eye drops (Drug)
Experimental group 1
1 drop each time, once every night at bedtime
干预措施: Low dose atropine sulfate eye drops (Drug)
Experimental group 2
1 drop each time, once every night at bedtime
干预措施: Low dose atropine sulfate eye drops (Drug)
control group
1 drop each time, once every night at bedtime
干预措施: placebo (Drug)
结局指标
主要结局
Cycloplegic Autorefraction(low)
时间窗: twelve months
Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with low atropine versus placebo.
次要结局
- Cycloplegic Autorefraction(lower)(twelve months)
- Cycloplegic Autorefraction(SER)(twelve months)