One Month Clinical Comparison of Lotrafilcon B and Samfilcon A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 主要终点
- Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
研究概览
简要总结
The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Sign informed consent document;
- •Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
- •Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
- •Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
- •History of herpetic keratitis, corneal surgery or irregular cornea;
- •Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
- •Monocular (only 1 eye with functional vision) or fit with only one lens;
- •Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
干预措施: Samfilcon A contact lenses (Device)
AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
干预措施: Lotrafilcon B contact lenses (Device)
AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
干预措施: Hydrogen peroxide solution (Device)
AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
干预措施: Saline solution (Device)
ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
干预措施: Lotrafilcon B contact lenses (Device)
ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
干预措施: Samfilcon A contact lenses (Device)
ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
干预措施: Hydrogen peroxide solution (Device)
ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
干预措施: Saline solution (Device)
结局指标
主要结局
Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
时间窗: Day 30, each product
The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.
次要结局
未报告次要终点