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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04763018
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Visual Display Users With Previously Undiagnosed Dry Eye Device: iTEAR100 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Day 14-30, all subjects receive therapy device
Masking: Double (Participant, 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
Primary Purpose: Treatment
Official Title: A Randomized Sham Controlled Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
Estimated Study Start Date : February 17, 2021
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Active Comparator: Treatment
This arm will receive a function iTEAR
Device: iTEAR100
Neurostimulation external nasal nerve to stimulate tear production

Sham Comparator: Sham
This arm will receive sham treatment device
Device: iTEAR100
Neurostimulation external nasal nerve to stimulate tear production




Primary Outcome Measures :
  1. Meibomian Gland change in expressibility [ Time Frame: 14 days ]
    Change in gland expression from meibomian glands

  2. Corneal Staining [ Time Frame: 14 days ]
    Change in Staining of cornea

  3. Basal tear output [ Time Frame: 14 days ]
    Change in the basal output of tears


Secondary Outcome Measures :
  1. Safety [ Time Frame: 30 days ]
    Incidence of Events which prevent device usage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763018


Contacts
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Contact: Michael gertner, MD 650-283-9388 mgertner@oo-med.com

Locations
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United States, California
Fishman Vision Recruiting
Palo Alto, California, United States, 94301
Sponsors and Collaborators
Olympic Ophthalmics, Inc.
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Responsible Party: Olympic Ophthalmics, Inc.
ClinicalTrials.gov Identifier: NCT04763018    
Other Study ID Numbers: CLP-OO8
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All results will be shared at conclusion of last follow up visit
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases