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

February 17, 2021 updated by: Olympic Ophthalmics, Inc.

A Randomized Sham Controlled Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Recruiting
        • Fishman Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
This arm will receive a function iTEAR
Device: iTEAR100
Neurostimulation external nasal nerve to stimulate tear production
Sham Comparator: Sham
This arm will receive sham treatment device
Device: iTEAR100
Neurostimulation external nasal nerve to stimulate tear production

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olympic Ophthalmics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 17, 2021

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

February 14, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-OO8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

December 2021

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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