Product Performance of Bausch & Lomb PureVision® Contact Lens When Compared to Johnson & Johnson Acuvue Oasys Contact Lens and the Ciba Vision O2Optix Contact Lens Worn Daily.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 510
- 试验地点
- 2
- 主要终点
- Any Slit Lamp Finding > Grade 2
研究概览
简要总结
The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily 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
- Supportive Care
- 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
- •Subject is myopic
- •VA correctable to 0.3 LogMAR or better (driving vision)
- •Clear central cornea
- •Subject uses a lens care system on a regular basis
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
结局指标
主要结局
Any Slit Lamp Finding > Grade 2
时间窗: Over all follow-up visits for the 1 month study period
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal \& bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.
Subjective Responses to Comfort-related Symptoms/Complaints
时间窗: Over all follow-up visits for 1 month study period
Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
Uncorrected Distance High Contrast Visual Acuity
时间窗: Over all visits for the 1 month study period
logMAR high contrast visual acuity (VA) over all visits.
次要结局
未报告次要终点