A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
研究概览
简要总结
The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.
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
- •Participants must have clear central corneas and be free of any anterior segment disorders.
- •Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.
排除标准
- •Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- •Participants with any systemic disease affecting ocular health.
- •Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Participants with an active ocular disease or are using any ocular medication.
- •Participants who have had any corneal surgery (eg, refractive surgery).
- •Participants who are allergic to any component in the study care products.
研究组 & 干预措施
Investigational contact lens
Bausch & Lomb
干预措施: Investigational contact lens (Device)
Acuvue Oasys Contact Lens
Johnson & Johnson Lens
干预措施: Acuvue Oasys Contact Lens (Device)
Air Optix Aqua
Ciba Vision
干预措施: Air Optix Aqua (Device)
结局指标
主要结局
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
时间窗: 7 days
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys
时间窗: 7 days
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
次要结局
- Lens Wettability, Test Lens vs. Acuvue Oasys(7 days)
- Lens Wettability, Test Lens vs. Air Optix Aqua(7 days)