Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Distance Visual Acuity (VA) With Study Lenses
研究概览
简要总结
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.
详细描述
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.
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
- •Able to understand and sign an IRB/IEC approved Informed Consent form.
- •Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
- •Best corrected visual acuity of 20/25 or better in each eye.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
- •Any habitual wear of Biofinity contact lenses.
- •Pregnant or breast-feeding.
- •Other protocol specified exclusion criteria may apply.
结局指标
主要结局
Distance Visual Acuity (VA) With Study Lenses
时间窗: Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters 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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
次要结局
未报告次要终点