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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.

Tracking Information
First Submitted Date  ICMJE February 14, 2021
First Posted Date  ICMJE February 21, 2021
Last Update Posted Date February 21, 2021
Estimated Study Start Date  ICMJE February 17, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
  • Meibomian Gland change in expressibility [ Time Frame: 14 days ]
    Change in gland expression from meibomian glands
  • Corneal Staining [ Time Frame: 14 days ]
    Change in Staining of cornea
  • Basal tear output [ Time Frame: 14 days ]
    Change in the basal output of tears
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
Safety [ Time Frame: 30 days ]
Incidence of Events which prevent device usage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
Official Title  ICMJE A Randomized Sham Controlled Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Visual Display Users With Previously Undiagnosed Dry Eye
Intervention  ICMJE Device: iTEAR100
Neurostimulation external nasal nerve to stimulate tear production
Study Arms  ICMJE
  • Active Comparator: Treatment
    This arm will receive a function iTEAR
    Intervention: Device: iTEAR100
  • Sham Comparator: Sham
    This arm will receive sham treatment device
    Intervention: Device: iTEAR100
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2021)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael gertner, MD 650-283-9388 mgertner@oo-med.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04763018
Other Study ID Numbers  ICMJE CLP-OO8
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All results will be shared at conclusion of last follow up visit
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: December 2021
Current Responsible Party Olympic Ophthalmics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Olympic Ophthalmics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Olympic Ophthalmics, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP