Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses

Alcon Research7 个研究点分布在 1 个国家目标入组 114 人2023年6月2日

适应症Refractive Errors Myopia

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Refractive Errors
发起方: Alcon Research
入组人数: 114
试验地点: 7
主要终点: Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4
状态: 已完成
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

详细描述

The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

注册库

clinicaltrials.gov

开始日期

2023年6月2日

结束日期

2023年6月27日

最后更新

去年

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Alcon Research

责任方

Sponsor

入排标准

入选标准

•Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
•Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
•Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
•Other protocol-specified inclusion criteria may apply.

排除标准

•Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
•Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
•Habitual monovision or multifocal contact lens wearers.
•Other protocol-specified exclusion criteria may apply.

结局指标

主要结局

Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4

时间窗: Day 4

VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.