Evaluation of Deposits on Contact Lenses Worn Extended Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Front Surface Lens Deposits
研究概览
简要总结
The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Age 18 or older.
- •Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
- •Successfully wearing hydrogel or silicone hydrogel contact lenses.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Evidence or history of ocular conditions as prescribed in the protocol.
- •One functional eye or a monofit lens.
- •Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
- •Use of concomitant topical ocular prescription or over-the-counter ocular medications.
- •History of seasonal allergies with significant ocular side effects.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Front Surface Lens Deposits
时间窗: 7 days
Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying \>25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits \<2 (less than grade 2 for both film and discrete) and into front surface lens deposits \>1 (greater than grade 1 for either film, discrete, or both).
次要结局
未报告次要终点