Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- High contrast visual acuity (logMAR) at 40cm
研究概览
简要总结
The purpose of this study is to measure the logMAR visual acuity when presbyopic soft lens wearers are fit with Dailies Total1 Multifocal and ACUVUE OASYS MAX 1-DAY Multifocal.
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
- 42 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are at least 42 years of age and has full legal capacity to volunteer;
- •Have signed an information consent letter;
- •Are willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wears soft contact lenses for the past 3 months (minimum);
- •Are presbyopic and require a reading addition of at least +0.75D and no more than +1.75D;
- •Can be refracted and achieve monocular spectacle distance vision of at least 20/25 Snellen (or +0.10logMAR) visual acuity;
- •Have contact lens power requirements that fall within the available study lens parameters (distance sphere: +6D to -9D; near addition as per each lens design);
- •Can be fit with the initial fitting guidelines provided by the lens manufacturer and use either Low or Medium Add (same add in both eyes).
排除标准
- •Are a current habitual wearer of Dailies Total1 Multifocal or ACUVUE OASYS MAX 1-DAY Multifocal;
- •Has refractive astigmatism higher than -0.75DC in either eye;
- •Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
- •Have any known active ocular disease and/or infection;
- •Has 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 known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Have undergone refractive error surgery;
- •Are a member of the Centre for Ocular Research & Education (CORE) directly involved in the study.
研究组 & 干预措施
Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal
Fit participant with Dailies Total1 Multifocal first, and with ACUVUE OASYS MAX 1-Day Multifocal second.
干预措施: Deleficon A (multifocal) (Device)
Dailies Total1 Multifocal, ACUVUE OASYS MAX 1-Day Multifocal
Fit participant with Dailies Total1 Multifocal first, and with ACUVUE OASYS MAX 1-Day Multifocal second.
干预措施: Senofilcon A (multifocal) (Device)
ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal
Fit participant with ACUVUE OASYS MAX 1-Day Multifocal first, and with Dailies Total1 Multifocal second.
干预措施: Deleficon A (multifocal) (Device)
ACUVUE OASYS MAX 1-Day Multifocal, Dailies Total1 Multifocal
Fit participant with ACUVUE OASYS MAX 1-Day Multifocal first, and with Dailies Total1 Multifocal second.
干预措施: Senofilcon A (multifocal) (Device)
结局指标
主要结局
High contrast visual acuity (logMAR) at 40cm
时间窗: Day 1
High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 40cm
High contrast visual acuity (logMAR) at 6m
时间窗: Day 1
High contrast visual acuity (logMAR) for the dominant eye under photopic illumination at 6m
次要结局
未报告次要终点