A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

Olympic Ophthalmics

Status and phase: Enrolling; Phase 1

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

Treatments: Device: iLIDS100

Study type: Interventional

Funder types: Industry

Identifiers

NCT06235450

CLP-012

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Therapeutic iLIDS arm

Experimental group

Description:

Subjects apply iTEAR100 device with iLIDS100 accessory

Treatment:

Device: iLIDS100