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临床试验/NCT05183022
NCT05183022已完成不适用

Do Total 30 Sphere Contact Lenses Provide a Comfortable Wearing Experience All Day?

University of Alabama at Birmingham3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
3
主要终点
Visual Analog Scale (VAS) Ocular Comfort

研究概览

简要总结

The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.

详细描述

Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Current contact lens wearers who have 20/20 visual acuity or better
  • Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10)
  • Astigmatism better than or equal to 0.50 D in each eye
  • Must have regularly worn 2 week or monthly contact lenses within the past 6 months
  • Must provide a glasses prescription that is is less than 3 years old
  • Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day

排除标准

  • Past or Current hard CL use
  • Any known systemic health conditions that are thought to alter tear film physiology
  • History of viral eye disease
  • History of ocular surgery
  • History of severe ocular trauma
  • Active ocular infection or inflammation
  • Currently using isotretinoin-derivatives
  • Currently using ocular medications
  • Currently using rewetting drops or artificial tear
  • Pregnant or breast feeding

结局指标

主要结局

Visual Analog Scale (VAS) Ocular Comfort

时间窗: 1 month

A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Pucker

Assistant Professor

University of Alabama at Birmingham

研究点 (3)

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