A Usability Study of External Neuromodulation With iTEAR1... | NCT05304650

Studies
A Usability Study of External Neuromodulation With iTEAR100 Generation 2

NCT05304650

Sponsor

Olympic Ophthalmics, Inc.

Status

Unknown status

Last Update Posted

Mar 31, 2022Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Dry Eye Syndromes

Interventions

iTEAR100

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Apr 30, 2022Estimated

Completion Date

Jun 15, 2022Estimated

First Submitted Date

Mar 1, 2022

First Submission Date that Met QC Criteria

Mar 30, 2022

First Posted Date

Mar 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2022

Last Update Posted Date

Mar 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iTEAR100 Therapy	Other	Treatment Arm. Assessment of usability of generation 2 connected devices	Device: iTEAR100

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iTEAR100	Device	Controlled Stimulation External Nasal Nerve to stimulate tear production	iTEAR100 Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Symptom Scores	OSDI and SPEED standard symptom scores	30 days
Adverse Events	Skin Damage, Headache, Dizziness, Sneezing	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Gertner	Contact	650-300-9340		clinicaltrials@oo-med.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Olympic Ophthalmics	Recruiting	Issaquah	Washington	98027	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided