NCT05529056招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Therapeutic Effect and Safety of LPTAT in Children With Myopia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 472
- 试验地点
- 15
- 主要终点
- Change in Spherical Equivalent over 12-month
研究概览
简要总结
This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.
详细描述
The primary objective is to evaluate the superiority of LPTAT to placebo in slowing myopia progression through the change of SE(Spherical Equivalent), which is measured by cycloplegic autorefraction after 12-month treatment.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5 to 12 years at the time of consent
- •Refractive error of SE at least -1.0 D and no greater than -8.0 D in both eyes as measured by cycloplegic autorefraction at visit 1 and visit
- •Confirmed myopia progression of 0.5D or more within past 1year
- •Astigmatism of 2.5D or less in both eyes
- •Distance Best Corrective Visual Acuity to logMAR 0.2 or better in both eyes at visit
- •Normal IOP under 21mmHg in both eyes.
- •Anisometropia of SE less than 2.0D as measured by cycloplegic autorefraction at visit
- •Written informed consent willingly obtained by both subject and his/her parents
排除标准
- •Hypersensitivity to atropine or other cycloplegic agent.
- •History of the surgery of refractive correction
- •Having ocular disease affect to visual function or refractive error: history of glaucoma, macula r degeneration, diabetic eye disease, uveitis, etc, or presence of conjunctivitis at screening visit.
- •Having systemic diseases that affect to vision loss
- •Having risk of IOP elevation such as narrow angle, Shallow Anterior Chambers, etc
- •Presence of binocular function disorder or stereopsis disorder
- •Amblyopia or manifest strabismus
- •History of premature birth(less than 37weeks) or low birth weight(less than 2,500g)
- •Previous or current use of atropine or Ortho-K lens for myopia
- •Down syndrome, spastic paralysis, brain damage, spastic palsy, bladder
- •Presence of neurological diseases like epilepsy, etc. which could expect difficulties in compliant to the ocular examinations.
- •Presence of clinically significant cardiac and respiratory diseases
- •Participation in any other clinical study of an investigational product within 3-month prior to current IP administration.
- •Based on the investigator's discretion, subject who is not proper to participate in the trial.
研究组 & 干预措施
Test Arm 1
Experimental
LPTAT01
干预措施: Atropine Sulfate 01 (Drug)
Test Arm 2
Experimental
LPTAT02
干预措施: Atropine Sulfate 02 (Drug)
Test Arm 3
Experimental
LPTAT03
干预措施: Atropine Sulfate 03 (Drug)
Reference Arm
Placebo Comparator
LPTAT04
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Spherical Equivalent over 12-month
时间窗: 12 months
Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline
次要结局
- Change in Spherical Equivalent(4, 8 months)
- Change in Axial length (mm)(4, 8, 12 months)
研究者
研究点 (15)
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