Evaluation of Wear Experience With PRECISION7® Contact Lenses in Habitual Acuvue® Oasys® Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Subjective Assessment of Lens Wear Experience
研究概览
简要总结
This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Ability to give informed consent
- •Current Acuvue® Oasys® spherical lens wearer.
- •Distance visual acuity of 20/25 or better with current contact lenses in each eye.
- •Good general health defined by, medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
- •Willing to spend time for the study, which includes: attend three study visits and wear contact lenses on days between study visits.
排除标准
- •Current or active ocular inflammation or infection as determined by the Investigator.
- •Currently pregnant or lactating. (Participants will be asked to self-report these conditions).
- •Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the investigator.
结局指标
主要结局
Subjective Assessment of Lens Wear Experience
时间窗: After 2 weeks of wear in the 1-week replacement reusable lenses.
Subjective assessment of lens wear experience using a CLDEQ-8 survey (contact lens dry eye questionnaire). There are 8 questions about about the presence and intensity of symptoms when wearing contact lenses. When totaling the scores for each question, the lowest possible score=1 and the highest possible score=37. Higher scores result from more prevalent and intense symptoms.
次要结局
未报告次要终点
研究者
Jennifer Fogt
Principal Investigator
Ohio State University