Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Visual Acuity (VA)
研究概览
简要总结
The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.
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)
盲法说明
Alcon Observer and Sponsor personnel were also masked.
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
- •Able to understand and sign an IRB-approved Informed Consent Form;
- •Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
- •Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
- •Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any anterior segment 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 plan to have refractive surgery during the study;
- •Ocular or intraocular surgery within the previous 12 months or planned during the study;
- •Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- •Any previous or current wear of MYDAY;
- •Habitually wearing monovision or multifocal lenses during the last 3 months;
- •Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
- •Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
FID122819, then stenfilcon A
FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week
干预措施: FID122819 contact lenses (Device)
FID122819, then stenfilcon A
FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week
干预措施: Stenfilcon A contact lenses (Device)
Stenfilcon A, then FID122819
Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week
干预措施: FID122819 contact lenses (Device)
Stenfilcon A, then FID122819
Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week
干预措施: Stenfilcon A contact lenses (Device)
结局指标
主要结局
Visual Acuity (VA)
时间窗: Baseline/Dispense (Day 1), Week 1, each product
VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.
次要结局
未报告次要终点