Evaluation of Deposits on Contact Lenses Worn Daily Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 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 front surface deposits on contact lenses when worn for ten hours.
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
- •18 years 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 prior to enrollment in the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye.
- •One functional eye or a monofit lens.
- •Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis.
- •Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol.
- •Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications.
- •History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Front Surface Lens Deposits
时间窗: 10 hours
Film and discrete deposits were assessed with a slit-lamp after 10 hours of 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