Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 5
- 主要终点
- Comfort on 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 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 was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. The habitual contact lenses were not optimized. There was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. Participants wore each study lens for 3-7 days and then attend a prescription optimization visit. After this optimization visit, they wore each study lens for a 2-week period. During the 2-week wear period, participants recorded their subjective lens-wear experience remotely.
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
- 42 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 42 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Self reports having a full eye examination in the previous two years;
- •Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
- •Has refractive astigmatism no higher than -0.75DC;
- •Is presbyopic and requires a reading addition of at least +0.75D and no more than
- •Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- •Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- •Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Has undergone refractive error surgery or intraocular surgery.
研究组 & 干预措施
Control Lens
All subjects will wear control lenses for two weeks and then will wear Test lenses for two weeks.
干预措施: Control lenses (Device)
Control Lens
All subjects will wear control lenses for two weeks and then will wear Test lenses for two weeks.
干预措施: Test lenses (Device)
Test Lens
After wearing control lenses for two weeks, all subjects will wear test lenses for two weeks.
干预措施: Control lenses (Device)
Test Lens
After wearing control lenses for two weeks, all subjects will wear test lenses for two weeks.
干预措施: Test lenses (Device)
结局指标
主要结局
Comfort on Insertion
时间窗: Day 1 after Lens Dispense Visit
Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).
次要结局
未报告次要终点