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临床试验/NCT05239494
NCT05239494已完成不适用

How Does DT1 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?

University of Alabama at Birmingham8 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月23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
60
试验地点
8
主要终点
Visual Analog Scale (VAS) Contact Lenses Comfort Scores

研究概览

简要总结

CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear." A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years.

Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • Adults 18-40
  • Past contact lens wearers who have best corrected 20/20 visual acuity or better
  • Participants will have had to have worn contact lenses for at least 1 year in the past
  • Dropped out of contact lenses in the past 2 years do to discomfort or dryness
  • Scores of 3 or less on the SPEED questionnaire
  • Be able to be refit into Dailies Total1 Sphere contact lenses
  • Provide a glasses prescription that is less than 3-years-old

排除标准

  • Past rigid contact lens wearers
  • A past history of being diagnosed with dry eye or ocular allergies
  • Known systemic health conditions that are known to alter tear film physiology
  • History of viral eye disease
  • History of ocular surgery
  • History of severe ocular trauma
  • History of corneal dystrophies or degeneration
  • Having active ocular infection or inflammation
  • Currently using isotretinoin-derivatives or ocular medication
  • Pregnant or breast feeding

结局指标

主要结局

Visual Analog Scale (VAS) Contact Lenses Comfort Scores

时间窗: 1 month

The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable).

次要结局

  • Likert Questionnaire(One Month)

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 (8)

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