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

Visual Display Users With Previously Undiagnosed Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04763018
• Other study ID #: CLP-OO8
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2021
• Source: Olympic Ophthalmics, Inc.
• Contact: Michael gertner, MD
• Phone: 650-283-9388
• Email: mgertner[@]oo-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Visual Display Users With Previously Undiagnosed Dry Eye

Intervention

Device:
• iTEAR100
Neurostimulation external nasal nerve to stimulate tear production

Locations

Country	Name	City	State
United States	Fishman Vision	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Olympic Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibomian Gland change in expressibility	Change in gland expression from meibomian glands	14 days
Primary	Corneal Staining	Change in Staining of cornea	14 days
Primary	Basal tear output	Change in the basal output of tears	14 days
Secondary	Safety	Incidence of Events which prevent device usage	30 days