NCT07104773已完成不适用
Clinical Investigation of Proclear® 1 Day and MyDay® Sphere Contact Lenses
CooperVision International Limited (CVIL)1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年7月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Subjective Comfort Rating
研究概览
简要总结
The aim of this study is to evaluate and compare the performance of two soft contact lenses.
详细描述
The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing soft lens wearers.
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
- •Are at least 18 years of age and have capacity to consent;
- •Have understood and signed an information consent form;
- •Are an adapted soft contact lens wearer (worn for at least 3 months);
- •Have a contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
- •Have a refraction with a cylinder component of no more than -0.75DC in each eye;
- •Can achieve a best spectacle-corrected visual acuity in each eye of +0.10 logMAR or better.
排除标准
- •Participation in a contact lens or contact lens care product clinical trial in the previous 30 days;
- •Have any known active anterior segment disease and/or infection or slit lamp findings that would contraindicate contact lens wear;
- •Have a systemic condition that would contraindicate contact lens wear;
- •Are using any systemic or topical medications that would contraindicate contact lens wear;
- •Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
- •Are an employee of the study site (Centre for Ocular Research & Education) and directly involved in the study (ie. on the delegation log).
研究组 & 干预措施
Control Lens (omafilcon A)
Experimental
All participants will wear Control Lens for 15 minutes (Period 1).
干预措施: Control Lens (omafilcon A) (Device)
Test Lens (stenfilcon A)
Experimental
All participants will wear Test Lens for 15 minutes (Period 2).
干预措施: Test Lens (stenfilcon A) (Device)
结局指标
主要结局
Subjective Comfort Rating
时间窗: At the end of 15 minutes of daily wear
The primary outcome of this study is lens comfort on a scale of 0-100 (0= worst, 100=best).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical Comparison of Two Daily Disposable Soft Contact LensesRefractive ErrorsMyopiaNCT03518008Alcon Research22
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
Clinical Comparison of Two Soft Contact LensesMyopiaNCT06251154CooperVision, Inc.50
已完成
不适用
Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day SphereMyopiaNCT06817785CooperVision, Inc.45
已完成
不适用
Two Week Cross-Over Study Comparing Two Daily Disposable Contact LensesMyopiaNCT01155323Johnson & Johnson Vision Care, Inc.118