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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04763018

Enrollment

Registered

2021-02-21

Start date

2021-02-17

Completion date

2021-06-01

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Display Users With Previously Undiagnosed Dry Eye

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.

Interventions

DEVICEiTEAR100

Neurostimulation external nasal nerve to stimulate tear production

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes 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

Intervention model description

Day 14-30, all subjects receive therapy device

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Safety	30 days	Incidence of Events which prevent device usage

Countries

United States

Contacts

Primary ContactMichael gertner, MD

mgertner@oo-med.com650-283-9388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026