A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

Olympic Ophthalmics, Inc.200 enrolled

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

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

Interventions

iLIDS100DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Olympic Ophthalmics

Issaquah, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

Questionnaire

How does iLids compare to NuLids product

Time frame: 30 days

Central Contacts

Michael Gertner, MD

CONTACT

650-283-9388 mgertner@oo-med.com

Data from ClinicalTrials.gov

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