NCT05917041已完成不适用
A Randomised, Open-label, Multicenter, Controlled, Exploratory Study on the Effect and Safety of SAT-001 as a Medical Device in Treatment of Pediatric Patients With Myopia
S-Alpha Therapeutics, Inc.12 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2021年3月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Change in axial length
研究概览
简要总结
The Purpose of this study is to explore the safety and effectiveness of SAT-001, a medical device for the treatment of myopia in pediatric patient with myopia
详细描述
Myopic pediatric prevalence rate come to increase rapidly globally. This is a clinical trial to explore the safety and effectiveness of SAT-001(as a Software as Medical Device) developed for the treatment of myopia through suppressing the progress myopia
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
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patient age 5 to 12 years old at the Screening Visit
- •Diagnosed with myopia as following refractive error via cycloplegic refraction(CR)
- •Spherical equivalent (SE) -0.75 D or more and less than -6.00 D in each eye
- •Astigmatism of 1.50 D or less in each eye
- •Anisometropia of less than 1.00 D
- •The age of birth over 38 weeks
- •Over 2500g of birth weight
- •Best corrected distance visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
- •Intraocular pressure 21 mmHg or less in each eye at the Screening Visit
排除标准
- •Administration of anti-muscarine drugs within 1 month before screening visit
- •Current or previous use of multi-focal lenses
- •Planning to use or having used Orthokeratology lenses (Ortho-K lenses), Rigid Gas Permeable (RGP) lenses, and other contact lenses to reduce the progression of myopia
- •History of atropine use for treatment of myopia within 1 month before screening visit
- •Abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit
- •History of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision)
- •History of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery)
- •Obsessive-compulsive disorder or attention deficit hyperactivity disorder(ADHD)
- •Down's syndrome or cerebral palsy
- •Participation in another clinical trial within 6 months before screening visit
- •History of growth hormone treatment within 1 month before screening visit
- •Medically clear to have abnormal range of intellectual development
- •Significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease
- •Currently taking or having taken antihistamines (tablets, nasal spray, eye drops, etc.) or psychiatric drugs (antidepressants, anti-anxiety medications, etc.) within 30 days before screening visit
- •History of injections with histamine release and cholinergic effect within 30 days before screening visit
- •Incongruent to participate in this study at the discretion of the investigator
结局指标
主要结局
Change in axial length
时间窗: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change in cycloplegic Refraction Error
时间窗: Baseline, 24 weeks, 48 weeks
次要结局
未报告次要终点
研究者
研究点 (12)
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