Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 9
- 主要终点
- Distance VA (logMAR) With Study Lenses - Completed Eyes
研究概览
简要总结
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.
详细描述
Subjects are expected to attend 6 study visits. The expected duration of study lens exposure 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
- •Successful wear of spherical daily wear frequent replacement 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 equal to or less than 0.75 diopter (D) in each eye.
- •Other protocol-specified 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.
- •Habitually wearing Biofinity contact lenses.
- •Monovision contact lens wearers.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Distance VA (logMAR) With Study Lenses - Completed Eyes
时间窗: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
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.
Distance VA (logMAR) With Study Lenses - Discontinued Eyes
时间窗: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up
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