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A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

Recruiting
18 years and older
All
Phase 1

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Overview

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.

Description

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

Eligibility

Inclusion Criteria:

Must use iTEAR and NuLids at time of enrollment

Exclusion Criteria:

  1. 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.

Study details
    MicroBlepharoexfoliation
    NuLids
    iTEAR100
    iLIDS100
    Blepharitis
    Dry Eye Syndrome

NCT06235450

Olympic Ophthalmics, Inc.

16 February 2024

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