NCT05579886已完成不适用
Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Comfort Just After Lens Insertion
研究概览
简要总结
The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks.
详细描述
This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.
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
- None
入排标准
- 年龄范围
- 42 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person was eligible for inclusion in the study if he/she:
- •Was at least 42 years of age and had full legal capacity to volunteer;
- •Had read and signed an information consent letter;
- •Self-reported having had a full eye examination in the previous two years;
- •Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
- •Was willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);
- •Had refractive astigmatism no higher than -0.75DC in each eye;
- •Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
- •Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)
排除标准
- •A person was excluded from the study if he/she:
- •Was participating in any concurrent clinical or research study;
- •Had any known active ocular disease and/or infection that contraindicated contact lens wear;
- •Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
- •Was using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
- •Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- •Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Had undergone refractive error surgery or interocular surgery.
研究组 & 干预措施
Control Lens
Active Comparator
All participants wore the Control Lens for 2 weeks (Period 1)
干预措施: Control Lens (Device)
Test Lens
Experimental
All participants wore the Test Lens for 2 weeks (Period 2)
干预措施: Test Lens (Device)
结局指标
主要结局
Comfort Just After Lens Insertion
时间窗: 2 weeks
Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.
次要结局
未报告次要终点
研究者
研究点 (5)
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