NCT05516082已完成不适用
Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Lens Fit Acceptance
研究概览
简要总结
This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.
详细描述
The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) 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 +8.00 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
时间窗: 15 minutes
Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. 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 (2)
Loading locations...
相似试验
已完成
不适用
Clinical Evaluation of Two Daily Disposable Lenses in NeophytesMyopiaNCT00987623CIBA VISION326
已完成
不适用
Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens WearersMyopiaNCT00958828CIBA VISION178
已完成
不适用
Clinical Evaluation of Two Daily Disposable Contact LensesRefractive ErrorNCT01163760Johnson & Johnson Vision Care, Inc.50
已完成
不适用
Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens WearersMyopiaNCT01134211CIBA VISION316
已完成
不适用
Evaluation of Etafilcon A Daily Disposable LensesMyopiaNCT02061592Johnson & Johnson Vision Care, Inc.136