Clinical Evaluation of ACUVUE® OASYS® 1-Day Daily Disposable Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
研究概览
简要总结
The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.
详细描述
After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (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 form;
- •Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;
- •Prescription within power range of both study contact lenses, as stated in the protocol;
- •Cylinder equal or lower than -0.75 diopter (D) in both eyes;
- •Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;
- •Willing to discontinue artificial tears and rewetting drops on the days of study visits;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •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;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Pregnant or lactating;
- •Current AO1D or AO lens wearer;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
AO1D, then AO
Senofilcon A contact lenses with HydraLuxe™, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
干预措施: Senofilcon A contact lenses with HydraLuxe™ (Device)
AO1D, then AO
Senofilcon A contact lenses with HydraLuxe™, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.
干预措施: Senofilcon A contact lenses (Device)
AO, then AO1D
Senofilcon A contact lenses, followed by senofilcon A contact lenses with HydraLuxe™. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
干预措施: Senofilcon A contact lenses with HydraLuxe™ (Device)
AO, then AO1D
Senofilcon A contact lenses, followed by senofilcon A contact lenses with HydraLuxe™. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
干预措施: Senofilcon A contact lenses (Device)
结局指标
主要结局
Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
时间窗: Day 10 ± 3 days, each product
Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
次要结局
- Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)(Day 10 ± 3 days, each product)
- Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)(Day 10 ± 3 days, each product)
- Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)(Day 10 ± 3 days, each product)