A Prospective Randomized Control Study to Evaluate the Effect of Ticon Aspherical Daily Disposable Soft Contact Lens on Myopia Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Spherical Equivalent Refraction (SER)
研究概览
简要总结
The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth
详细描述
This study is designed as a prospective, multicenter, randomized, double blinded, controlled, paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D in the past 12 months will be recruited from 2 study sites. The experimental soft contact lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right eye or the left eye of the subject , then the fellow eye will be assigned a control lens with a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8 hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3, 6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary outcome measure is used to corroborate any changes in SER
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
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopia (SE) between -1.00D to -8.00D
- •Astigmatism less than or equal to 1.75D
- •Myopia progression ≧0.75 D in the past 12 months
- •Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better
- •Willingness to wear contact lens constantly
- •Availability for follow-up for at least 1 year
- •Parent's understanding and acceptance
- •have an acceptable surrogate capable of giving legally authorized consent on behalf of the subject
排除标准
- •Anisometropia greater than 2.00D
- •Presence of ocular disease preventing wear of contact lens
- •Severe ocular or systemic allergies
- •Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
- •Ocular or systemic condition that might affect refractive development
- •Atropine/Pirenzepine treatment for myopia control in the past 1 month
- •Prior use of Ortho-K lenses
- •Dry eye with Schimer Test (basal secretion test) < 5mm/5min or other physical condition that would contraindicate contact lens wear
研究组 & 干预措施
Ticon Aspherical Daily Disposable Soft Contact Lens
The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.
干预措施: soft contact lens (Device)
Ticon Daily Soft Contact Lens
The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.
干预措施: soft contact lens (Device)
结局指标
主要结局
Spherical Equivalent Refraction (SER)
时间窗: 12 months
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
次要结局
- Axial Eye Length (AXL)(12 months)