1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Contact Lenses Compared to Ultra for Presbyopia Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual Acuity (Distance)
研究概览
简要总结
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 40 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent.
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Have no active ocular disease or allergic conjunctivitis.
- •Not be using any topical ocular medications.
- •Be willing and able to follow instructions.
- •Have signed a statement of informed consent.
排除标准
- •Participating in a conflicting study.
- •Considered by the Investigator to not be a suitable candidate for participation.
研究组 & 干预措施
kalifilcon A First, Then samfilcon A for Presbyopia
Participants wore kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable, for approximately 1 week.
干预措施: kalifilcon A Daily Disposable Multifocal (Device)
kalifilcon A First, Then samfilcon A for Presbyopia
Participants wore kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable, for approximately 1 week.
干预措施: samfilcon A for Presbyopia (Device)
samfilcon A for Presbyopia First, Then kalifilcon A
Participants wore Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable, for approximately 1 week.
干预措施: kalifilcon A Daily Disposable Multifocal (Device)
samfilcon A for Presbyopia First, Then kalifilcon A
Participants wore Ultra for Presbyopia (samfilcon A) Low and High Add lenses bilaterally, daily-disposable/single-use, for approximately 1 week, then crossed over to kalifilcon A Daily Disposable Multifocal (Low Add and High Add) lenses bilaterally, daily-disposable, for approximately 1 week.
干预措施: samfilcon A for Presbyopia (Device)
结局指标
主要结局
Visual Acuity (Distance)
时间窗: One week (follow-up visit)
Mean Binocular logMAR Visual Acuity at Distance (6m)
Visual Acuity (Near)
时间窗: One week (follow-up)
Mean Binocular logMAR Visual Acuity at Near (40cm)
次要结局
未报告次要终点