Study of External Neuromodulation to Improve Signs and Sy... | NCT04763018

Studies
Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users

NCT04763018

Sponsor

Olympic Ophthalmics, Inc.

Status

Unknown status

Last Update Posted

Feb 21, 2021Actual

Enrollment

35Estimated

Phase

Not Applicable

Conditions

Visual Display Users With Previously Undiagnosed Dry Eye

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

Feb 2021

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

Feb 17, 2021Estimated

Primary Completion Date

May 1, 2021Estimated

Completion Date

Jun 1, 2021Estimated

First Submitted Date

Feb 14, 2021

First Submission Date that Met QC Criteria

Feb 17, 2021

First Posted Date

Feb 21, 2021Actual

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

Feb 17, 2021

Last Update Posted Date

Feb 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Two study arms - sham and treatment; There will be a cross over of the sham group to the treatment group at day 15.

Detailed Description

This is a post market study. The active device will be the FDA cleared device used within its labeling. The sham group will receive an iTEAR device which looks identical to and makes noise similar to a fully functional iTEAR device but has a tip that does not vibrate. All subjects in the sham group will crossover to the treatment group after 2 two weeks and all patients will continue to 30 days.

The study will be conducted at up to 5 sites in the United States. It will enroll 30 subjects for 30 days.

This is a double-masked study with 10 subjects receiving sham and 20 subjects receiving treatment. The subjects and the examining investigators are masked to treatment until the crossover.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Active Comparator	This arm will receive a function iTEAR	Device: iTEAR100
Sham	Sham Comparator	This arm will receive sham treatment device	Device: iTEAR100

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iTEAR100	Device	Neurostimulation external nasal nerve to stimulate tear production	Sham Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Meibomian Gland change in expressibility	Change in gland expression from meibomian glands	14 days
Corneal Staining	Change in Staining of cornea	14 days
Basal tear output	Change in the basal output of tears	14 days

Secondary Outcomes

Measure	Description	Time Frame
Safety	Incidence of Events which prevent device usage	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 6hrs visual display terminal
OSDI > 13
One of: SChirmer < 10, One quadrant staining > 2, or Meibomian Gland expression <12

Exclusion Criteria:

Opinion of investigator that subject not be in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael gertner, MD	Contact	650-283-9388		mgertner@oo-med.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fishman Vision	Recruiting	Palo Alto	California	94301	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All results will be shared at conclusion of last follow up visit

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

December 2021

Access Criteria

Not provided

URL

Not provided

Masking Info

Masking

Double

Masking Description

Sham device produces noise but no stimulation energy. Assessor does not know which device the subject received. The subject does not know which device he or she received

Who Masked

ParticipantOutcomes Assessor