Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- Lens Handling for Removal
研究概览
简要总结
The objective of the study was to compare the lens performance of two daily disposable multifocal contact lenses.
详细描述
This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 3-4 weeks: the lens prescription of each lens type was optimized after a 3-8 days wearing experience, then participants began a 2 week (14-21 day) wear period.
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
- Single (Participant)
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
- •Were 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
- •Were willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wore multifocal soft contact lenses, for the past 3 months minimum
- •Maximum of 7 participants per site were habitual wearers of daily disposable lenses
- •Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal
- •Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL
- •Maximum of 3 habitual wearers per site of MyDay Multifocal
- •Maximum of 7 participants per site were habitual wearers of frequent replacement lenses
- •Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA
- •Had refractive astigmatism no higher than -0.75DC in each eye;
- •Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;
- •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, near addition as per study design)
排除标准
- •A person was excluded from the study if they:
- •Were 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;
- •Were 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, then Test Lens
Participants wore Control Lens for 2 weeks, then crossed over to Test Lens for 2 weeks.
干预措施: Control Lens (stenfilcon A) (Device)
Control Lens, then Test Lens
Participants wore Control Lens for 2 weeks, then crossed over to Test Lens for 2 weeks.
干预措施: Test Lens (senofilcon A) (Device)
Test Lens, then Control Lens
Participants wore Test Lens for 2 weeks, then crossed over to Control Lens for 2 weeks.
干预措施: Control Lens (stenfilcon A) (Device)
Test Lens, then Control Lens
Participants wore Test Lens for 2 weeks, then crossed over to Control Lens for 2 weeks.
干预措施: Test Lens (senofilcon A) (Device)
结局指标
主要结局
Lens Handling for Removal
时间窗: 2 Weeks
Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear.
次要结局
未报告次要终点