A Usability Study of External Neuromodulation With iTEAR100 Generation 2

Sponsor

Olympic Ophthalmics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05304650

Collaborator

(none)

100

Enrollment

Location

Arm

3.5

Anticipated Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Device: iTEAR100	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open Label StudyOpen Label Study

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Usability Study of External Neuromodulation With iTEAR100 Generation 2

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: iTEAR100 Therapy Treatment Arm. Assessment of usability of generation 2 connected devices	Device: iTEAR100 Controlled Stimulation External Nasal Nerve to stimulate tear production

Arm

Intervention/Treatment

Other: iTEAR100 Therapy

Treatment Arm. Assessment of usability of generation 2 connected devices

Device: iTEAR100

Controlled Stimulation External Nasal Nerve to stimulate tear production

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Olympic Ophthalmics	Issaquah	Washington	United States	98027

Sponsors and Collaborators

Olympic Ophthalmics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Olympic Ophthalmics, Inc.

ClinicalTrials.gov Identifier:

NCT05304650

Other Study ID Numbers:

clp 010

First Posted:

Mar 31, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dry Eye Syndromes

Study Results

No Results Posted as of Mar 31, 2022