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

Olympic Ophthalmics

Status: Unknown

Conditions: Visual Display Users With Previously Undiagnosed Dry Eye

Treatments: Device: iTEAR100

Study type: Interventional

Funder types: Industry

Identifiers

NCT04763018

CLP-OO8

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Treatment

Active Comparator group

Description:

This arm will receive a function iTEAR

Treatment:

Device: iTEAR100

Sham

Sham Comparator group

Description:

This arm will receive sham treatment device

Treatment:

Device: iTEAR100