A Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- Symptoms and Complaints
研究概览
简要总结
The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Subjects must have clear central corneas and be free of any anterior segment disorders.
- •Subjects must be adapted wearers of one of the listed contact lenses
- •Subjects must be myopic
- •Subjects must use a lens care system on a regular basis.
排除标准
- •Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
- •Subjects with any systemic disease affecting ocular health.
- •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 are using any ocular medication.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Subjects who have had any corneal surgery (eg, refractive surgery).
- •Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
研究组 & 干预措施
Redesigned Purevision Contact Lens
Redesigned Bausch & Lomb PureVision contact lens
干预措施: Redesigned Purevision Contact Lens (Device)
PureVision Contact Lens
Bausch & Lomb PureVision contact lens
干预措施: PureVision Contact Lens (Device)
结局指标
主要结局
Symptoms and Complaints
时间窗: 1 month
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.
次要结局
- Visual Acuity(1 month)
- Percentage of Eyes With > Grade 2 Slit Lamp Findings(1 month)