A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

Last updated: January 23, 2024
Sponsor: Olympic Ophthalmics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Blepharitis

Treatment

iLIDS100

Clinical Study ID

NCT06235450
CLP-012
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Must use iTEAR and NuLids at time of enrollment

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: iLIDS100
Phase: 1
Study Start date:
January 19, 2024
Estimated Completion Date:
December 31, 2025

Study 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

Connect with a study center

  • Olympic Ophthalmics

    Issaquah, Washington 98027
    United States

    Active - Recruiting

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