Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Overall Quality of Vision
研究概览
简要总结
The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.
详细描述
The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.
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 must sign an approved Informed Consent Form
- •Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
- •Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
- •Willing to stop wearing habitual contact lenses for the duration of study participation
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
- •Routinely sleeps in habitual contact lenses
- •Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
DD T2/Oasys 1-Day
Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized
干预措施: verofilcon A contact lenses (Device)
DD T2/Oasys 1-Day
Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized
干预措施: senofilcon A contact lenses (Device)
DD T2/MyDay
Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
干预措施: verofilcon A contact lenses (Device)
DD T2/MyDay
Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
干预措施: stenfilcon A contact lenses (Device)
DD T2/Moist
Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
干预措施: verofilcon A contact lenses (Device)
DD T2/Moist
Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
干预措施: etafilcon A contact lenses (Device)
结局指标
主要结局
Overall Quality of Vision
时间窗: Day 8, each product
Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.
次要结局
未报告次要终点