Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
- Conditions
- Visual Display Users With Previously Undiagnosed Dry Eye
- Registration Number
- NCT04763018
- Lead Sponsor
- Olympic Ophthalmics, Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
- > 6hrs visual display terminal
- OSDI > 13
- One of: SChirmer < 10, One quadrant staining > 2, or Meibomian Gland expression <12
- Opinion of investigator that subject not be in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety 30 days Incidence of Events which prevent device usage
Trial Locations
- Locations (1)
Fishman Vision
🇺🇸Palo Alto, California, United States
Fishman Vision🇺🇸Palo Alto, California, United States