Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 504
- 试验地点
- 50
- 主要终点
- Rate of Contact Lens Related Serious and Significant Events (SSE)
研究概览
简要总结
Study in the US intended to evaluate the safety and effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •The subject must be at least 18 years of age.
- •The subject must read and sign the statement of informed consent and be provided with a copy of the form.
- •Minimum of 7 days of successful lens wear
- •Contact lens prescription requiring between -1.00 to -6.00 D spherical power
- •Less than 1.00 D of astigmatism in either eye
排除标准
- 未提供
研究组 & 干预措施
Control
etafilcon A contact lens being worn 7 days/6 nights.
干预措施: etafilcon A (Device)
Test
galyfilcon A contact lens being worn 7 days/6 nights.
干预措施: galyfilcon A (Device)
结局指标
主要结局
Rate of Contact Lens Related Serious and Significant Events (SSE)
时间窗: Throughout the duration of the study (1 Year)
The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40
时间窗: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks
Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.
次要结局
未报告次要终点