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

Primary Purpose

Visual Display Users With Previously Undiagnosed Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTEAR100
Sponsored by
Olympic Ophthalmics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Display Users With Previously Undiagnosed Dry Eye

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fishman VisionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment

Sham

Arm Description

This arm will receive a function iTEAR

This arm will receive sham treatment device

Outcomes

Primary Outcome Measures

Meibomian Gland change in expressibility
Change in gland expression from meibomian glands
Corneal Staining
Change in Staining of cornea
Basal tear output
Change in the basal output of tears

Secondary Outcome Measures

Safety
Incidence of Events which prevent device usage

Full Information

First Posted
February 14, 2021
Last Updated
February 17, 2021
Sponsor
Olympic Ophthalmics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04763018
Brief Title
Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
Official Title
A Randomized Sham Controlled Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2021 (Anticipated)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympic Ophthalmics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Display Users With Previously Undiagnosed Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Day 14-30, all subjects receive therapy device
Masking
ParticipantOutcomes Assessor
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
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
This arm will receive a function iTEAR
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
This arm will receive sham treatment device
Intervention Type
Device
Intervention Name(s)
iTEAR100
Intervention Description
Neurostimulation external nasal nerve to stimulate tear production
Primary Outcome Measure Information:
Title
Meibomian Gland change in expressibility
Description
Change in gland expression from meibomian glands
Time Frame
14 days
Title
Corneal Staining
Description
Change in Staining of cornea
Time Frame
14 days
Title
Basal tear output
Description
Change in the basal output of tears
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Safety
Description
Incidence of Events which prevent device usage
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael gertner, MD
Phone
650-283-9388
Email
mgertner@oo-med.com
Facility Information:
Facility Name
Fishman Vision
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All results will be shared at conclusion of last follow up visit
IPD Sharing Time Frame
December 2021

Learn more about this trial

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

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