NCT05656885已完成不适用
Clinical Evaluation of Proclear Monthly and Avaira Vitality
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Lens Fit Acceptance Rating
研究概览
简要总结
This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.
详细描述
The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical 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
- 是
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 at least 8 hours a day, 5 days a week.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
- •Has refractive astigmatism no higher than -0.75DC.
- •Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)
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.
研究组 & 干预措施
Lens A
Experimental
All participants wore Lens A for 15 minutes (Period 1)
干预措施: Lens A (Device)
Lens B
Experimental
All participants wore Lens B for 15 minutes (Period 2)
干预措施: Lens B (Device)
结局指标
主要结局
Lens Fit Acceptance Rating
时间窗: 15 minutes
Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.
次要结局
未报告次要终点
研究者
研究点 (1)
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