NCT06611410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
- 10
- 试验地点
- 2
- 主要终点
- High Contrast, Binocular, Distance Visual Acuity (logMAR)
研究概览
简要总结
The objective of this investigation is to compare the visual clinical performance of two daily disposable soft contact lenses.
详细描述
This is a prospective, multiple day, double (investigator and subject) masked, randomized, bilateral crossover study comparing a Test lens against an appropriate Control lens. Main aim is to compare visual acuity and subjective vision ratings of vision quality between two lenses in habitual soft lens wearers.
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 (inclusively)
- •Have read, signed and dated:
- •Age 18 - The Participant Informed Consent Form (participant only)
- •Age 12-17 - The Parental Permission Form (participant and parent)
- •Age 8-11 - The Parental Permission Form (parent) and Assent form (participant)
- •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, including myopia control soft contact lenses as below-
- •Currently wears spherical soft contact lenses or myopia control soft contact 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 contact 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 contact lenses.
- •Have worn any rigid contact lenses or ortho-keratology contact lenses in the past 30 days.
- •Are an extended contact lens wearer (i.e., sleeping with their contact 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 CORL directly involved in the study.
结局指标
主要结局
High Contrast, Binocular, Distance Visual Acuity (logMAR)
时间窗: At the end of one week wear
High contrast, binocular, distance visual acuity (logMAR) will be measured at 1-week visit.
次要结局
- Subjective Vision Quality(At the end of one week wear)
研究者
研究点 (2)
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