Performance Assessment of a Modified Daily Disposable Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- High Contrast Distance Visual Acuity (logMAR)
研究概览
简要总结
The purpose of this study is to compare visual acuity between two daily disposable contact lenses.
详细描述
The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an approved Informed Consent form;
- •Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
- •Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
- •Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
- •Monocular (only one eye with functional vision);
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
MDACL, then DACL
Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
干预措施: Delefilcon A contact lenses (Device)
MDACL, then DACL
Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
干预措施: Modified delefilcon A contact lenses (Device)
DACL, then MDACL
DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
干预措施: Modified delefilcon A contact lenses (Device)
DACL, then MDACL
DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
干预措施: Delefilcon A contact lenses (Device)
结局指标
主要结局
High Contrast Distance Visual Acuity (logMAR)
时间窗: Day 1 Dispense, Day 7 Follow-Up
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
次要结局
未报告次要终点