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A Usability Study of External Neuromodulation With iTEAR100 Generation 2

NCT ID: NCT05304650

Last Updated: 2022-03-31

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-06-15

Brief Summary

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A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment.

Detailed Description

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A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment. Subjects sign a consent form and are sent a device. After downloading a mobile app, they can access the device and download a prescription. At 7 days, an official telehealth visit evaluates their success in the set up and training. At 30 days, the trial ends, A usability survey and symptom evaluation survey are used to determine success.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Open Label Study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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iTEAR100 Therapy

Treatment Arm. Assessment of usability of generation 2 connected devices

Group Type OTHER

iTEAR100

Intervention Type DEVICE

Controlled Stimulation External Nasal Nerve to stimulate tear production

Interventions

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iTEAR100

Controlled Stimulation External Nasal Nerve to stimulate tear production

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Olympic Ophthalmics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Olympic Ophthalmics

Issaquah, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Gertner

Role: CONTACT

Phone: 650-300-9340

Email: [email protected]

Facility Contacts

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Michael Gertner

Role: primary

Other Identifiers

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clp 010

Identifier Type: -

Identifier Source: org_study_id