NCT07790640进行中（未招募）3 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-design, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Change in Spherical Equivalent (SE) The change from baseline in spherical equivalent (SE) at 12 months after administration, to evaluate the superiority of the myopia progression control effect of the treatment groups compared with the control group.
研究概览
简要总结
This study was to evaluate the superiority of the myopia progression control effect in the treatment group compared with the control group, evaluated by the change in spherical equivalent (SE) after 12 months of administration of the investigational product.
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
- •Children aged ≥5 years and ≤12 years at the time of informed consent.
- •Participants who meet all of the following refractive criteria in both eyes at screening and randomization:
- •- Spherical equivalent (SE) between -1.00 D and -7.00 D
- •Participants with myopia progression of ≥0.50 D in both eyes within the past year.
- •Participants with distance-corrected visual acuity of 0.2 (logMAR) or better in both eyes at screening.
- •Participants whose parent voluntarily provided written informed consent for participation in the clinical trial (or the participant and one of the participant's parents provided written informed consent).
排除标准
- •Participants who have undergone vision correction surgery or procedures.
- •Participants with ocular surgery within 6 months before screening or planned ocular surgery during the study.
- •Participants with macular degeneration, congenital retinal disease, cataract, or other optic nerve disease affecting vision.
- •Participants with impaired binocular or stereoscopic vision.
- •Participants with chronic or recurrent inflammatory ocular disease or active ocular infection.
- •Participants with prior use of atropine eye drops for myopia control before screening.
- •Participants with prior use of myopia control lenses or spectacles, except those who discontinued due to intolerance or lack of efficacy and completed a ≥12-week washout period.
- •Participants with corneal abnormalities that may interfere with visual acuity assessment, including corneal opacity, scarring, dystrophy, or dysplasia.
- •Participants who require or are expected to require contact lens use during the study.
- •Participants with a history of hypersensitivity to any component of the investigational product.
- •Participants with diseases requiring caution with any component of the investigational product, including:
- •Down syndrome
- •Voiding dysfunction due to bladder weakness, megacolon, or acute pulmonary edema
- •History of sensitivity to belladonna alkaloids
- •Participants with Marfan syndrome, Stickler syndrome, retinopathy of prematurity, Ehlers-Danlos syndrome, or progressive retinal atrophy that may cause severe myopia.
- •Participants who have undergone organ or bone marrow transplantation.
- •Participants with brain disease that may affect visual acuity.
- •Participants with clinically significant cardiovascular or respiratory disease or spastic paralysis due to brain injury, including cerebral palsy.
- •Participants who were born prematurely or with low birth weight, unless currently above the normal range according to growth charts.
- •Participants who received another investigational drug within 30 days before study participation.
- •Participants with any other disease or condition that, in the investigator's judgment, may affect the efficacy or safety assessment or make the participant unsuitable for the study.
研究组 & 干预措施
CTO0308-C
Experimental
Ophthalmic solution
干预措施: CTO0308 (Drug)
CTO0308-D
Placebo Comparator
Vehicle
干预措施: Vehicle (Placebo solution) (Drug)
CTO0308-A
Experimental
Ophthalmic solution
干预措施: CTO0308 (Drug)
CTO0308-B
Experimental
Ophthalmic solution
干预措施: CTO0308 (Drug)
结局指标
主要结局
Change in Spherical Equivalent (SE) The change from baseline in spherical equivalent (SE) at 12 months after administration, to evaluate the superiority of the myopia progression control effect of the treatment groups compared with the control group.
时间窗: Month 12
Change in Spherical Equivalent (SE)
时间窗: Month 12
The change in spherical equivalent (SE) at 12 months from baseline
次要结局
- Change in Axial Length The change from baseline in axial length after administration of the investigational product.(Months 4, 8 and 12)
- Change in Spherical Equivalent (SE) The change from baseline in spherical equivalent (SE) after administration of the investigational product.(Months 4 and 8)
- Proportion of Participants With Myopia Progression of Less Than 0.5 D The proportion of participants with myopia progression of less than 0.5 D from baseline after administration of the investigational product.(Month 12)
- Change in Axial Length(Months 4, 8 and 12)
- Change in Spherical Equivalent (SE)(Months 4 and 8)
- Proportion of Participants With Myopia Progression of less Than 0.5 D(Month 12)
研究者
研究点 (1)
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