NCT06400914已完成不适用
Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Lens Fit Acceptance Ratings
研究概览
简要总结
The aim of this study is to compare the short-term clinical performance of two sphere contact lenses.
详细描述
The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and signed an information consent letter.
- •Self-reports having a full eye examination in the previous two years.
- •Anticipates being able to wear the study lenses for the required time of the study.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Has refractive astigmatism no higher than -0.75 DC.
- •Can be fit with the available lens parameters (sphere +6.00 to -10.00D).
- •Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.
排除标准
- •Is participating in any concurrent clinical or research study.
- •Has any known active ocular disease and/or infection that contraindicates contact lens wear.
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
- •Has known sensitivity to the diagnostic sodium fluorescein used in the study.
- •Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
- •Has undergone refractive error surgery or intraocular surgery.
结局指标
主要结局
Lens Fit Acceptance Ratings
时间窗: At the end of 15 Minutes of wear
Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Clinical Evaluation of Two Toric Soft Contact LensesAstigmatismNCT06490302CooperVision, Inc.40
已完成
不适用
A Clinical Comparison of Two Soft Contact Lenses (C24-755)HyperopiaMyopiaNCT06758076CooperVision, Inc.52
已完成
不适用
A Clinical Comparison of Two Soft Contact LensesMyopiaHyperopiaNCT05741450Coopervision, Inc.45
已完成
不适用
A Comparison of Two Contact LensesMyopiaRefractive ErrorNCT00700752Johnson & Johnson Vision Care, Inc.40
已完成
不适用
Clinical Comparison of Two Soft Contact LensesMyopiaNCT06251154Coopervision, Inc.50