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NCT05304650 Clinical Trial

A Usability Study of External Neuromodulation With iTEAR100 Generation 2

Dry Eye Syndromes Clinical Trial

Official title:
A Usability Study of External Neuromodulation With iTEAR100 Generation 2

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05304650
Other study ID # clp 010
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2022
Est. completion date June 15, 2022

Study information
Verified date March 2022
Source Olympic Ophthalmics, Inc.
Contact Michael Gertner
Phone 650-300-9340
Email clinicaltrials@oo-med.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 15, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Able to sign English language consent form and over age 18 and reside in the U.S. - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• iTEAR100
Controlled Stimulation External Nasal Nerve to stimulate tear production

Locations
Country Name City State
United States Olympic Ophthalmics Issaquah Washington

Sponsors (1)
Lead Sponsor Collaborator
Olympic Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Usability Subjects rate the device usability similar to daily mobile applications and home devices using a scale from -3 to +3 with 0 being same as every day devices such as bank application, restaurant application, etc. 30 days
Secondary Symptom Scores OSDI and SPEED standard symptom scores 30 days
Secondary Adverse Events Skin Damage, Headache, Dizziness, Sneezing 30 days
Secondary Symptom Score SPEED standard symptom score 30 Days
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