A Usability Study of External Neuromodulation With iTEAR100 Generation 2

Phase 4

• Conditions: Dry Eye Syndromes

• Registration Number: NCT05304650
• Lead Sponsor: Olympic Ophthalmics, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-30
• Last Update Submitted: 2022-03-30
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-04-30
• Study Completion: 2022-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Able to sign English language consent form and over age 18 and reside in the U.S.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Usability	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	30 days	Skin Damage, Headache, Dizziness, Sneezing
Symptom Score	30 Days	SPEED standard symptom score
Symptom Scores	30 days	OSDI and SPEED standard symptom scores

Trial Locations

Locations (1)

Olympic Ophthalmics; 🇺🇸 Issaquah, Washington, United States