NCT04763018

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Olympic Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Visual Display Users With Previously Undiagnosed Dry Eye

Interventions

Type	Name	Description
DEVICE	iTEAR100	Neurostimulation external nasal nerve to stimulate tear production

Timeline

• Start date: 2021-02-17
• Primary completion: 2021-05-01
• Completion: 2021-06-01
• First posted: 2021-02-21
• Last updated: 2021-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study