A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Distance High Contrast logMAR Visual Acuity at 1 Week
研究概览
简要总结
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational 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
- 是
入选标准
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.
排除标准
- •Any systemic disease affecting ocular health.
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Allergic to any component in the study care products.
研究组 & 干预措施
Investigational Lens
Bausch & Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.
干预措施: Investigational Lens (Device)
Investigational Lens
Bausch & Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.
干预措施: Air Optix Aqua lens (Device)
Air Optix Aqua Lens
Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.
干预措施: Investigational Lens (Device)
Air Optix Aqua Lens
Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.
干预措施: Air Optix Aqua lens (Device)
结局指标
主要结局
Distance High Contrast logMAR Visual Acuity at 1 Week
时间窗: Baseline & 1 week
Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week
次要结局
- Slit Lamp Findings ≥ Grade 2(1 week)
- Overall Comfort(1 week)