NCT06232590已完成不适用
Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Lens Handling for Insertion
研究概览
简要总结
To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.
详细描述
This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) 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 spherical multifocal soft contact lenses, for the past 3 months minimum:
- •Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses,
- •Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal,
- •Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
- •Had refractive astigmatism no higher than -0.75DC;
- •Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
- •Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).
排除标准
- •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 or ocular 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 affect contact lens wear or a study outcome variable;
- •Had known sensitivity to the diagnostic sodium fluorescein used in the study;
- •Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Had undergone refractive error surgery or intraocular surgery.
结局指标
主要结局
Lens Handling for Insertion
时间窗: 1 month
Subjective rating collected in office using a 0-100 scale, where 0=Very difficult and 100=Very easy. The participant rated the study lens considering a typical day in the last 1 month of wear.
次要结局
未报告次要终点
研究者
研究点 (10)
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