Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 8
- 主要终点
- Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
研究概览
简要总结
The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.
详细描述
Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).
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
- 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 informed consent form that has been approved by an Institutional Review Board.
- •Willing and able to attend all study visits as required by the protocol.
- •Willing to stop wearing habitual contact lenses for the duration of the study.
- •Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any eye infection, inflammation, 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 planning to have refractive surgery during the study.
- •Current or history of pathologically dry eye.
- •Currently pregnant or lactating.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
LID210464, then AOHG MF
Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
干预措施: Lehfilcon A multifocal contact lenses (Device)
LID210464, then AOHG MF
Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
干预措施: Lotrafilcon B multifocal contact lenses (Device)
LID210464, then AOHG MF
Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
干预措施: CLEAR CARE® (Device)
AOHG MF, then LID210464
Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
干预措施: Lehfilcon A multifocal contact lenses (Device)
AOHG MF, then LID210464
Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
干预措施: Lotrafilcon B multifocal contact lenses (Device)
AOHG MF, then LID210464
Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
干预措施: CLEAR CARE® (Device)
结局指标
主要结局
Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
时间窗: Day 30, each wear period. A wear period was approximately 30 days.
Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
次要结局
未报告次要终点