A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-19

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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MicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Label, Prospective, Therapeutic Intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapeutic iLIDS arm

Subjects apply iTEAR100 device with iLIDS100 accessory

Group Type EXPERIMENTAL

iLIDS100

Intervention Type DEVICE

Subject applies iLIDS accessory to the iTEAR100 device. Applies to Eyelid margin similar to commercial products

Interventions

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iLIDS100

Subject applies iLIDS accessory to the iTEAR100 device. Applies to Eyelid margin similar to commercial products

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No