A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 30
- 主要终点
- Dryness Averaged Over All Follow-up Visits
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
- •Subjects must be habitual wearers of included contact lenses.
- •Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- •Subjects must agree to wear their lenses on a daily wear basis for approximately 1 month.
排除标准
- •Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
结局指标
主要结局
Dryness Averaged Over All Follow-up Visits
时间窗: 1 month
Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean dryness over all follow-up visits will be computed as the average of the non-missing values over all scheduled follow-up visits.
Overall Comfort Averaged Over All Follow-up Visits
时间窗: 1 month
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean overall comfort over all follow-up visits will be computed as the average of the non-missing values overall scheduled follow-up visits.
Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit
时间窗: 1 month
At each follow-up visit, graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than grade 2 at any visit (Absent, Present).
次要结局
未报告次要终点