Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Distance Visual Acuity (VA)
研究概览
简要总结
The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily 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
- Single (Participant)
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 informed consent form approved by an Institutional review board (IRB);
- •Successful wear of spherical monthly replacement 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 (BCVA) 20/25 or better in each eye;
- •Willing to stop wearing habitual contact lenses for the duration of study participation.
排除标准
- •Any conditions or use of medications that could contraindicate contact lens wear;
- •History of or plan to have refractive surgery in either eye;
- •Irregular cornea in either eye;
- •Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
- •Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
- •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;
- •Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
- •Habitual Biofinity contact lens wearers.
研究组 & 干预措施
LID014341
LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis
干预措施: LID014341 contact lenses (Device)
Biofinity
Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis
干预措施: Comfilcon A contact lenses (Device)
结局指标
主要结局
Distance Visual Acuity (VA)
时间窗: Day 30
VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.
次要结局
未报告次要终点