Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
研究概览
简要总结
The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an informed consent form;
- •Habitual current daily disposable soft contact lenses wearer;
- •Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
- •Lenses within the power range specified in the protocol;
- •Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
- •Acceptable lens fit with both study contact lenses;
- •Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Currently wearing DT1 or TE sphere lenses;
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- •Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
- •Eye injury or surgery within 12 weeks immediately prior to enrollment;
- •History of herpetic keratitis, ocular surgery or irregular cornea;
- •Prior refractive surgery;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Participation in any clinical trial within 30 days of the enrollment visit;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
DT1, then TE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
干预措施: Delefilcon A contact lenses (Device)
DT1, then TE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
干预措施: Narafilcon A contact lenses (Device)
TE, then DT1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
干预措施: Delefilcon A contact lenses (Device)
TE, then DT1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
干预措施: Narafilcon A contact lenses (Device)
结局指标
主要结局
Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
时间窗: Day 10, each product
Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.
次要结局
未报告次要终点