Recruiting

External Neuromodulation

Sponsor:

Olympic Ophthalmics, Inc.

Code:

NCT04763018

Conditions

Visual Display Users With Previously Undiagnosed Dry Eye

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

Interventions

iTEAR100

Study Details

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.

Conditions

Visual Display Users With Previously Undiagnosed Dry Eye

Study ID

NCT04763018

Start date

Feb 17, 2021

Status verified date

Feb, 2021

Completion date

Jun 1, 2021

Anticipated

Primary completion date

May 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment

This arm will receive a function iTEAR

sham comparator: Sham

This arm will receive sham treatment device

Interventions

iTEAR100

Neurostimulation external nasal nerve to stimulate tear production

Primary outcome measure

  • Meibomian Gland change in expressibility [ Time Frame: 14 days ]
  • Corneal Staining [ Time Frame: 14 days ]
  • Basal tear output [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Michael gertner, MD

650-283-9388mgertner@oo-med.com

Locations

Fishman Vision

Recruiting

Palo Alto, California, United States, 94301

More Information

Sponsor

Olympic Ophthalmics, Inc.

Last update posted

Feb 21, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Olympic Ophthalmics, Inc. on 2021-02-21.