Clinical Validation of DACP Digital Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Distance Visual Acuity (VA) (logMAR, OU)
研究概览
简要总结
The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to sign an IRB/IEC approved Informed Consent form;
- •Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
- •Experiencing symptoms of eye strain from using technology;
- •Willing to wear study lenses each day;
- •Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
- •Willing to NOT use rewetting/lubricating drops at any time during the study;
- •Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
- •Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.
排除标准
- •Conditions, use of medications, injury, or surgery, as specified in the protocol;
- •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;
- •Monocular (only one eye with functional vision);
- •Pregnant.
研究组 & 干预措施
DACP Digital then DACP
Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.
干预措施: Nelfilcon A contact lenses (Device)
DACP Digital then DACP
Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.
干预措施: Nelfilcon A digital contact lenses (Device)
DACP then DACP Digital
Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.
干预措施: Nelfilcon A digital contact lenses (Device)
DACP then DACP Digital
Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.
干预措施: Nelfilcon A contact lenses (Device)
结局指标
主要结局
Distance Visual Acuity (VA) (logMAR, OU)
时间窗: Day 7, each product
VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.
次要结局
- Overall Vision(Day 7, each product)