A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Subjective Responses to Symptoms/Complaints
研究概览
简要总结
The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •subject is myopic
- •VA correctable to 0.3 logMAR or better (driving vision)
- •Clear central cornea
排除标准
- •Systemic disease affecting ocular health
- •using systemic or topical medications
- •wear monovision, multifocal or toric contact lenses
- •Any grade 2 or greater slit lamp findings
研究组 & 干预措施
Purevision Contact Lens #1
PureVision Soft Contact Lens Design (currently marketed)
干预措施: Currently Marketed PureVision Contact Lens. (Device)
PureVision Contact Lens #2
Redesign of the currently marketed PureVision soft contact lens.
干预措施: Alternate Design of the PureVision Contact Lens. (Device)
结局指标
主要结局
Subjective Responses to Symptoms/Complaints
时间窗: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits
Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.
次要结局
- LogMAR Visual Acuity(Mean over all visits - 1 day, 1 week, 1 month)
- Lens Characteristics(Over all scheduled visits day 1 - 1 month)