Two Daily Disposable Contact Lenses in Symptomatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- Monocular Corrected Distance Visual Acuity (VA)
研究概览
简要总结
The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.
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
- None
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 must sign an IRB-approved informed consent form;
- •Soft contact lens wearers in both eyes during the past 3 months;
- •Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- •Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
- •Willing to stop wearing habitual contact lenses for the duration of study participation.
排除标准
- •Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
- •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;
- •Monocular (only one eye with functional vision).
研究组 & 干预措施
TOTAL1
Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality
干预措施: Delefilcon A contact lenses (Device)
1-DAY
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
干预措施: Senofilcon A contact lenses (Device)
结局指标
主要结局
Monocular Corrected Distance Visual Acuity (VA)
时间窗: Week 4
Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.
次要结局
未报告次要终点