Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 35
- 主要终点
- Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
研究概览
简要总结
The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.
详细描述
Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Understand and sign an IRB/IEC approved Informed Consent form.
- •Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
- •Successful wear of frequent replacement, spherical, daily wear soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- •Manifest cylinder ≤ 0.75 diopter (D) in each eye.
- •Best spectacle corrected visual acuity 20/20 or better in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- •Monovision contact lens wear.
- •Any habitual wear of Biofinity lenses.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
时间窗: Week 1 Follow-Up
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
次要结局
- Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)(Week 1 Follow-Up, at least 4 hours after lens insertion)