Clinical Validation Study of Phoebe Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Corneal Staining Extent
研究概览
简要总结
The purpose of this study is to validate the clinical performance of a new contact lens design.
详细描述
Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double masked (participant, investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Corneal Staining Extent
时间窗: Day 3
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).
Palpebral Hyperemia on Upper Lid
时间窗: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid
时间窗: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Conjunctival Staining Score
时间窗: Day 3
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Palpebral Hyperemia on Lower Lid
时间窗: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid
时间窗: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
次要结局
- Distance Visual Acuity(Day 3)
- Near Visual Acuity(Day 3)
- Vision Quality Rating(Day 3)