Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users

University of Waterloo1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2019年12月13日最近更新: 2023年1月26日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Waterloo
入组人数: 32
试验地点: 1
主要终点: Subjective Rating of Clarity of Vision After Contact Lens Insertion

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
•Has read and signed an information consent letter;
•Is willing and able to follow instructions and maintain the appointment schedule;
•Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
•Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;
•Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;
•Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
•Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
•Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day throughout the study;

排除标准

•Is participating in any concurrent clinical or research study;
•Has any known active* ocular disease and/or infection;
•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 a study outcome variable;
•Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
•Is pregnant, lactating or planning a pregnancy at the time of enrolment;
•Is aphakic;
•Has undergone refractive error surgery;
•For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

研究组 & 干预措施

Refit

Experimental

Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance.

干预措施: Verofilcon A contact lenses (Device)