Atropine in the Treatment of Myopia Study in Malaysia (ATOM-MY): A Randomized, Double-Blind Study to Demonstrate the Efficacy and Safety of Eye Drop Formulations (Atropine Sulphate 0.025 % w/v Eye Drops vs Placebo) in the Management of Controlling Progression of Myopia in Children.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- To demonstrate the superiority of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) against placebo determined by Spherical equivalent
研究概览
简要总结
This clinical trial is designed to assess the efficacy and safety of Atropine Sulphate 0.025% w/v Eye Drops compared to placebo in a randomized, double-blind, placebo-controlled study for the management of myopia progression in children.
详细描述
Myopia represents the most prevalent refractive error globally, with its incidence rising significantly over recent decades, particularly in East Asian populations. Current projections estimate that by the year 2050, nearly 50% of the global population will be affected by myopia, with approximately 10% classified as high myopes. High myopia is characterized by axial elongation of the eye and is associated with an elevated risk of severe ocular complications, including early-onset cataracts, glaucoma, retinal detachment, choroidal neovascularization, myopic macular degeneration, and macular hemorrhage. Given its increasing prevalence and potential for vision-threatening outcomes, myopia constitutes a substantial public health issue, contributing to considerable healthcare and socioeconomic burdens. Therefore, the development of safe and effective interventions to mitigate the progression of myopia is of critical importance.
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 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children between 5 to 10 years of age.
- •Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
- •Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
- •Children with astigmatism of less than -1.50 D
- •Children having distance vision correctable to logMAR 0.2 or better in both eyes.
- •A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D.
- •Children with normal intraocular pressure of not greater than 21 mmHg in either eye.
- •Children with normal ocular health other than myopia.
- •Children must be in good general health with no history of cardiac or respiratory diseases as per investigator's discretion and does not affect the study treatment or subsequent follow-ups.
- •No asthma-requiring medications in the past one year.
- •No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride.
- •Willing and able to comply with scheduled visits and other study procedures.
- •Written Informed Consent from parent and assent from child has been obtained.
排除标准
- •History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients.
- •Children with prior and/or concomitant use of other myopia control drugs, contact lens or spectacles (except normal spectacles including tinted/anti-glare glasses) etc.
- •Children with congenital myopia.
- •Children using Ortho K and Myopia Lens.
- •Children with ocular or systemic diseases which may affect vision or refractive error.
- •Children with any ocular condition wherein topical atropine is contraindicated.
- •Children with defective binocular function or stereopsis.
- •Children with amblyopia (lazy eyes) or manifest strabismus including intermittent tropia.
- •Previous or current use of atropine or pirenzepine.
- •Children with any other conditions precluding adherence to the protocol including unwillingness to refrain from the use of other myopia control drug, contact lens or spectacles (except normal) spectacles including tinted/anti-glare glasses) etc. for the duration of the study.
- •Children with any other condition which may put the subject to risk during study or affect study results based on investigator's judgement.
- •Children participated in any clinical study within 30 days prior to randomization.
研究组 & 干预措施
Atropine Sulphate 0.025% w/v Eye Drops
Participants will be instructed to administer one drop of Atropine Sulphate 0.025% w/v Eye Drops into each eye once daily at bedtime for a duration of 24 months.
干预措施: Low dose atropine sulfate eye drops (Drug)
Placebo
Participants will be instructed to administer one drop of Placebo Eye Drops into each eye once daily at bedtime for a duration of 12 months and Atropine Sulphate 0.025% w/v Eye Drops from 13-24 months onwards.
干预措施: Placebo (Drug)
结局指标
主要结局
To demonstrate the superiority of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) against placebo determined by Spherical equivalent
时间窗: 12 months
Spherical equivalent refraction determined by cycloplegic autorefraction from baseline to 12 months at each visit.
次要结局
- To demonstrate continued efficacy of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) of 24 months with the comparison of 12 months by spherical equivalent(24 months)
- To demonstrate the superiority of eye drop formulation (Atropine Sulpahte 0.025% w/v Eye Drops) against placebo by axial length(12 months)