Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
研究概览
简要总结
The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.
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
- Single (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
- •Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
- •Require vision correction in both eyes.
- •Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
- •Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
- •Willing and able to wear study contact lenses 16 hours per day.
- •Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
- •Require monovision correction.
- •Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
- •Ocular surgery/trauma within the last 6 months.
- •Topical or systemic antibiotic use within 7 days of enrollment.
- •Topical ocular or systemic corticosteroid use within 14 days of enrollment.
- •Pregnant and nursing women.
- •Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
时间窗: Day 7, 16 hours after lens insertion
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.
次要结局
未报告次要终点