跳至主要内容
临床试验/NCT03969290
NCT03969290
已完成
不适用

Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Alcon Research1 个研究点 分布在 1 个国家目标入组 69 人2019年6月5日

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
69
试验地点
1
主要终点
End of day (EOD) visual acuity at distance
状态
已完成
最后更新
6年前

概览

简要总结

The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

详细描述

The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

注册库
clinicaltrials.gov
开始日期
2019年6月5日
结束日期
2019年8月5日
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Able to understand and sign an approved Informed Consent form
  • Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
  • Best corrected VA of logMAR 0.10 or better in each eye
  • Willing to discontinue artificial tears and rewetting drops during the study
  • Able to wear contact lenses within the protocol-specified sphere power range
  • Other protocol-specified inclusion criteria may apply.

排除标准

  • Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
  • History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
  • 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
  • Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
  • Other protocol-specified exclusion criteria may apply.

结局指标

主要结局

End of day (EOD) visual acuity at distance

时间窗: Day 1, after 8 hours of wear

Visual acuity (VA) will be measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity.

研究点 (1)

Loading locations...

相似试验