A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 8
- 主要终点
- Change in Refractive Error Relative to Baseline
研究概览
简要总结
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
详细描述
Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 8 and 12 years of age inclusive.
- •Best-corrected visual acuity by manifest refraction of +0.10 logMAR.
- •Spherical Equivalent Refractive Error between -0.75 and -4.00 D
- •inclusive astigmatism: < -0.75 D and anisometropia: < 1.00 D
- •Possess wearable and visually functional eyeglasses.
- •Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study.
排除标准
- •Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.
- •Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
- •Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
- •Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
- •Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
- •A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
- •Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
- •Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
结局指标
主要结局
Change in Refractive Error Relative to Baseline
时间窗: 36 months
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Change in Axial Length Relative to Baseline
时间窗: 36 months
Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.
次要结局
- Number of Participants With Biomicroscopic Findings Greater Than Grade 2(12 months)
- Number of Participants With Biomicroscopic Findings(24 months)
- Number of Participants With Biomicroscopic Findings Greater Than Grade 2.(36 months)
- Incidence of Adverse Events(36 months)