Characterization of Pre-Lens Tear Film Stability of Daily Disposable Multifocal and Toric Contact Lenses Using Ring Mire Projection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
研究概览
简要总结
The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.
详细描述
Two population groups (presbyopes and astigmats) will be enrolled in the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an informed consent document;
- •Adapted, current soft contact lens wearer with either:
- •A spectacle add between +0.50 and +2.50 (inclusive) [Presbyopes group]
- •A spherical correction of an astigmatism up to 20% of the amount of the sphere [Astigmats group];
- •Contact lens prescription in the power range specified in the protocol;
- •Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
- •Willing to wear study lenses up to 12 hours and attend all study visits;
- •Can be successfully fitted with study lenses;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- •Use of artificial tears and rewetting drops during the study;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Pregnant or lactating;
- •Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;
- •Participation in any clinical study within 30 days of Visit 1;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
时间窗: Hour 12, each product
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
次要结局
- Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear(Hour 8, each product)