Status:
UNKNOWN
Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
Lead Sponsor:
Olympic Ophthalmics, Inc.
Conditions:
Visual Display Users With Previously Undiagnosed Dry Eye
Eligibility:
All Genders
18-69 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- \> 6hrs visual display terminal
- OSDI \> 13
- One of: SChirmer \< 10, One quadrant staining \> 2, or Meibomian Gland expression \<12
Exclusion
- Opinion of investigator that subject not be in the study
Key Trial Info
Start Date :
February 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04763018
Start Date
February 17 2021
End Date
June 1 2021
Last Update
February 21 2021
Active Locations (1)
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1
Fishman Vision
Palo Alto, California, United States, 94301