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临床试验/NCT06235450
NCT06235450招募中1 期

A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

Olympic Ophthalmics, Inc.2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月19日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
200
试验地点
2
主要终点
Questionnaire

研究概览

简要总结

The purpose of this study is to evaluate the usability of the iTEAR100 generation 2 device in combination with its newly developed iLIDS100 disposable cover.

详细描述

This usability study is meant to validate treatment using the iLIDS100 in patients who already use the NuLids Device and iTEAR100. The patients will simply substitute the iLIDS100 cover in combination with the iTEAR100 for the NuLids product and otherwise maintain their same treatment regimen. The planned number of subjects was chosen to provide clinically relevant usability data

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must use iTEAR and NuLids at time of enrollment

排除标准

  • have any condition, which in the judgment of the PI would prevent a potential subject from safely completing the study or tolerating device use, such as mental illness, dementia, severe agitation, etc. and including inability to comply with the treatment regimen.

结局指标

主要结局

Questionnaire

时间窗: 30 days

How does iLids compare to NuLids product

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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