NCT01309867已完成不适用
A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
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
- 302
- 试验地点
- 1
- 主要终点
- Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.
研究概览
简要总结
The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Subjects must have clear central corneas and be free of any anterior segment disorders.
- •Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
- •Subjects must be myopic and require lens correction
- •Subjects must be habitual wearers of toric soft contact lenses.
排除标准
- •Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
- •Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Subjects with an active ocular disease or who are using any ocular medication.
- •Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Subjects who are allergic to any component in the study care products.
研究组 & 干预措施
Investigational Toric Lens
Experimental
Bausch + Lomb investigational toric contact lenses
干预措施: Investigational Toric Lens (Device)
PureVision Toric Lens
Active Comparator
Currently marketed Bausch + Lomb PureVision toric contact lenses
干预措施: PureVision Toric Lens (Device)
结局指标
主要结局
Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.
时间窗: 2 weeks
Visual Acuity
时间窗: 2 weeks
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
次要结局
- Symptoms and Complaints(2 weeks)
- Percentage of Eyes With > Grade 2 Slit Lamp Findings(2 weeks)
研究者
研究点 (1)
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