NCT06873048已完成不适用
Short-term Study of Myday Sphere and Myday Toric Lenses in Existing Spherical Soft Contact Lenses Wearers With Low Astigmatism (Pacific)
CooperVision International Limited (CVIL)1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年2月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Contact Lens Comfort
研究概览
简要总结
The primary objective of the study is to evaluate and compare the performance of two soft contact lens.
详细描述
The primary objective of the study is to evaluate and compare the performance of two different soft contact lens in existing spherical soft contact lens (CL) wearers with low levels of refractive astigmatism over a 2-week wear period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 17 Years 至 42 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 17 years and no more than 42 years of age.
- •Have read and signed the study consent form.
- •Are willing and able to follow instructions and maintain the appointment schedule.
- •Are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency.
- •Are willing to wear the study contact lenses for 6 days a week while in this study and on three days (day 1, Day 7 and Day 13) for at least 12 hours.
- •Are willing to provide a contact email and telephone number and to use a device that allows them to respond to a short online questionnaire every 3 hours on days 1, 7 and 13 of each lens arm, while wearing one of the 2 study lenses.
- •Are non-presbyopic i.e. no requirement for a reading addition for routine daily tasks (self report).
- •Have astigmatism of either -0.50, -0.75, -1.00 or -1.25 DC in each eye by subjective sphero-cylindrical refraction.
- •Achieves at least 0.10 LogMAR in each eye by subjective sphero-cylindrical refraction.
- •Can be fit with available study contact lens powers of between +6.00 to -10.00 DS.
- •Demonstrate an acceptable fit with the study contact lenses.
排除标准
- •Are participating in any concurrent clinical interventional study.
- •Have worn rigid contact lenses in the last 3 months.
- •Have worn soft toric contact lenses in the past 3 months.
- •Have any known active ocular disease or allergies and/or infection.
- •Have clinically significant biomicroscopy findings or have an ocular condition that contraindicate contact lens wear.
- •Have a systemic condition that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
- •Have known sensitivity to the diagnostic sodium fluorescein to be used in the study.
- •Have undergone refractive error surgery or intraocular surgery.
- •Are an employee of the Centre for Ocular Research & Education directly involved in this study.
研究组 & 干预措施
Control Contact Lens (stenfilcon A Sphere)
Experimental
All participants will wear Control Contact Lens for one week (Period 1).
干预措施: Control Contact Lens (stenfilcon A Sphere) (Device)
Test Contact Lens (stenfilcon A Toric)
Experimental
All participants will wear Test Contact Lens for one week (Period 2).
干预措施: Test Contact Lens (stenfilcon A Toric) (Device)
结局指标
主要结局
Contact Lens Comfort
时间窗: Day 1 (day after dispense), Day 7 and Day 13 at 12 hours contact lens wear
Contact lens comfort will be measured on the scale of 0-100 where, (0=worst and 100=best)
次要结局
未报告次要终点
研究者
研究点 (1)
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