Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
研究概览
简要总结
The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.
详细描述
Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
- •Willing to stop wearing habitual contact lenses for the duration of study participation;
- •Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
- •History of refractive surgery, or plan to have refractive surgery during the study;
- •Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
- •Monovision contact lens wear;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
LID#224381, then AOHG MF
Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
干预措施: Lehfilcon A multifocal contact lenses (Device)
LID#224381, then AOHG MF
Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
干预措施: Lotrafilcon B multifocal contact lenses (Device)
LID#224381, then AOHG MF
Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
干预措施: Hydrogen peroxide-based cleaning and disinfection system (Device)
AOHG MF, then LID#224381
Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
干预措施: Lehfilcon A multifocal contact lenses (Device)
AOHG MF, then LID#224381
Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
干预措施: Lotrafilcon B multifocal contact lenses (Device)
AOHG MF, then LID#224381
Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.
干预措施: Hydrogen peroxide-based cleaning and disinfection system (Device)
结局指标
主要结局
Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)
时间窗: Day 2, each study lens type worn during the corresponding crossover period
VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was prespecified for this endpoint.
次要结局
未报告次要终点