NCT06170658已完成不适用
1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- High contrast, binocular, distance visual acuity
研究概览
简要总结
The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.
详细描述
This is a prospective, bilateral, double masked (participant and investigator), randomized, cross-over dispensing study with 1 week wearing period in each arm by comparing visual acuity and subjective vision quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 8 to 18 years of age inclusive and have full legal capacity to volunteer;
- •Have read and signed and dated the Parental Permission Form (for those aged 16 and younger); participant has read, signed and dated the study Information Consent Letter (if aged 17 or 18 years) or Assent (aged 16 and younger);
- •Are willing and able to follow instructions and maintain the appointment schedule;
- •Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye;
- •Currently wears spherical soft contact lenses or myopia control soft lenses;
- •Have a pair of wearable back-up spectacles;
- •Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;
- •Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D
- •Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction;
- •Have clear corneas with no corneal scars or any active ocular disease;
- •Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit.
- •Demonstrate an acceptable fit with the study lenses.
- •Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit;
排除标准
- •Have taken part in another clinical research study within the last 14 days;
- •Are currently habitual wearers of toric lenses.
- •Have worn any rigid contact lenses or ortho-keratology lenses in the past 30 days
- •Are an extended lens wearer (i.e., sleeping with their lenses)
- •Are on ongoing atropine treatment for myopia control
- •Have a difference of > 1.0 D in best vision sphere subjective refraction between eyes;
- •Have amblyopia and/or strabismus/binocular vision problem
- •Have any known active ocular disease, allergies and/or infection;
- •Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Have undergone refractive error surgery or intraocular surgery;
- •Are a member of CORE directly involved in the study.
结局指标
主要结局
High contrast, binocular, distance visual acuity
时间窗: 7 days
Distance visual acuity (LogMAR) will be measured using high and low contrast computer-generated acuity charts.
次要结局
- Subjective Vision Quality(7 days)
研究者
研究点 (2)
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