NCT05304650

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 1, 2022

Last Update Submit

March 30, 2022

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Symptom Scores

    30 days

  • Adverse Events

    30 days

  • Symptom Score

    30 Days

Study Arms (1)

iTEAR100 Therapy

OTHER

Treatment Arm. Assessment of usability of generation 2 connected devices

Device: iTEAR100

Interventions

iTEAR100DEVICE

Controlled Stimulation External Nasal Nerve to stimulate tear production

iTEAR100 Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olympic Ophthalmics

Issaquah, Washington, 98027, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Michael Gertner

CONTACT

650-300-9340clinicaltrials@oo-med.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Open Label Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 31, 2022

Study Start

March 1, 2022

Primary Completion

April 30, 2022

Study Completion

June 15, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

US(1)