NCT05333965已完成不适用
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Lens Handling on Lens Removal
研究概览
简要总结
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
详细描述
This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Self-reports having had a full eye examination within the previous 2 years;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is a habitual wearer of frequent replacement contact lenses;
- •Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
- •Has refractive astigmatism no higher than -0.75DC in each eye;
- •Can be successfully fit with both study lens types;
- •Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.
排除标准
- •Is participating in any concurrent clinical research study;
- •Has any known active ocular disease and/or infection;
- •Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- •Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- •Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- •Is an employee of the Centre for Ocular Research & Education.
结局指标
主要结局
Lens Handling on Lens Removal
时间窗: 1 month
Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)
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
Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise UseAmetropiaNCT05166902Coopervision, Inc.67
已完成
不适用
Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens TypesPresbyopiaNCT06232590CooperVision International Limited (CVIL)60
已完成
不适用
Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens WearersMyopiaHyperopiaNCT05114564Coopervision, Inc.66
已完成
不适用
Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four WeeksMyopiaPresbyopiaAstigmatismNCT01293240CIBA VISION117
已完成
不适用
Evaluation of Two Silicone Hydrogel Lenses Over a One Month PeriodMyopiaNCT00810511CIBA VISION213