One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
研究概览
简要总结
The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.
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
- •Sign Informed Consent;
- •Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;
- •Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;
- •Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;
- •Screening lenses worn 10 hours exhibiting high lipid uptake.
排除标准
- •Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months;
- •Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;
- •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 for which contact lens wear could be contraindicated, as determined by the Investigator;
- •Abnormal ocular conditions or findings, as specified in the protocol;
- •Known pregnancy and lactation.
研究组 & 干预措施
Lotrafilcon B, then senofilcon C
Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
干预措施: Lotrafilcon B contact lenses (Device)
Lotrafilcon B, then senofilcon C
Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
干预措施: Senofilcon C contact lenses (Device)
Senofilcon C, then lotrafilcon B
Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
干预措施: Lotrafilcon B contact lenses (Device)
Senofilcon C, then lotrafilcon B
Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.
干预措施: Senofilcon C contact lenses (Device)
结局指标
主要结局
Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
时间窗: Day 30 after 10 hours of wear, each product
Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.
次要结局
未报告次要终点