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

Last updated: February 17, 2021
Sponsor: Olympic Ophthalmics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dry Eyes

Sjogren's Syndrome

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT04763018
CLP-OO8
  • Ages 18-69
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Opinion of investigator that subject not be in the study

Study Design

Total Participants: 35
Study Start date:
February 17, 2021
Estimated Completion Date:
June 01, 2021

Study 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.

Connect with a study center

  • Fishman Vision

    Palo Alto, California 94301
    United States

    Active - Recruiting

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