Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 5
- 主要终点
- Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"
研究概览
简要总结
The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.
详细描述
Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign informed consent
- •Habitually wear multifocal soft/ silicone hydrogel contact lenses
- •Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive)
- •Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance
- •Willing to wear contact lenses and attend all study visits
排除标准
- •Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses
- •Any eye condition that would make contact lens wear unadvisable
- •Any use of medication that would make contact lens wear unadvisable
- •Prior refractive surgery
研究组 & 干预措施
DT1MF, then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
干预措施: Delefilcon A multifocal contact lenses (Device)
DT1MF, then AMMF
Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
干预措施: Etafilcon A multifocal contact lenses (Device)
AMMF, then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
干预措施: Delefilcon A multifocal contact lenses (Device)
AMMF, then DT1MF
Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
干预措施: Etafilcon A multifocal contact lenses (Device)
结局指标
主要结局
Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"
时间窗: Day 14, each product
Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.
次要结局
未报告次要终点