NCT06579287进行中（未招募）2 期
A Phase II Study to Determine the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution on Myopia Control in Subjects Aged 3-12 Years.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 9
- 主要终点
- Change of the cycloplegic spherical equivalent (SE)
研究概览
简要总结
The objective of this study is to explore the safety and efficacy of SHJ002 Sterile Ophthalmic Solution relative to atropine in myopia control
SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female, age 3-12 years (inclusive).
- •Cycloplegic sphere of -1.00 D or worse in both eyes
- •Able to complete all study assessments and comply with the protocol
- •Literate or able to orally communicate.
- •Parent or guardian able and willing to provide written informed consent
- •Parent or guardian able and willing to assure subject compliance with the protocol, follow study instructions, and attend study visits
- •Able to tolerate eye drops in both eyes.
- •Be able and willing to avoid all disallowed medications and refractive correction
- •For female subjects of childbearing potential (those who have experienced menarche and who are not surgically sterilized [bilateral tubal ligation, hysterectomy, or bilateral oophorectomy]), a negative urinary test.
- •Women of childbearing potential must agree to use two reliable methods of contraception
- •Males not naturally or surgically sterile, who have a female partner of childbearing potential, must agree to use two reliable methods of contraception
排除标准
- •Axial length > 26 mm
- •Anisometropia
- •Astigmatism > 2.00 D
- •Intraocular pressure > 21 mm Hg or < 6 mm Hg
- •Active or recent history of severe ocular infection or inflammation
- •Previous incisional or laser surgery
- •Any clinically significant finding on slit lamp biomicroscopy or ophthalmoscopy
研究组 & 干预措施
SHJ002
Experimental
The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.
干预措施: SHJ002 (Drug)
Atropine
Active Comparator
The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.
干预措施: Atropine (Drug)
结局指标
主要结局
Change of the cycloplegic spherical equivalent (SE)
时间窗: from baseline visit to the final visit, up to 52 weeks
次要结局
- Change of axial length(from baseline visit to the final visit, up to 52 weeks)
研究者
研究点 (9)
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