NCT01412983已完成不适用
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Acuity
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 developed by Bausch + Lomb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
- •Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- •Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.
排除标准
- •An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- •Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- •Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Any scar or neovascularization within the central 4mm of the cornea.
- •Have had any corneal surgery.
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Any systemic disease affecting ocular health.
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •Currently wear monovision, multifocal, or toric contact lenses.
- •Allergic to any component in the study care products.
研究组 & 干预措施
Bausch & Lomb Test Lens
Experimental
Bausch + Lomb investigational soft contact lens
干预措施: Bausch & Lomb Test lens (Device)
Ciba Vision soft contact lens
Active Comparator
Ciba Vision Air Optix Aqua soft contact lens
干预措施: Ciba Vision soft contact lens (Device)
结局指标
主要结局
Visual Acuity
时间窗: One week
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
次要结局
- Overall Comfort(One week)
研究者
研究点 (1)
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