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

Not Applicable

• Conditions: Visual Display Users With Previously Undiagnosed Dry Eye
• Interventions: Device: iTEAR100

• Registration Number: NCT04763018
• Lead Sponsor: Olympic Ophthalmics, Inc.

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-14
• Study Start: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	iTEAR100	This arm will receive a function iTEAR
Sham	iTEAR100	This arm will receive sham treatment device

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety	30 days	Incidence of Events which prevent device usage

Trial Locations

Locations (1)

Fishman Vision; 🇺🇸 Palo Alto, California, United States