Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients
Primary Purpose
Dry Eye
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
iTEAR100 treatment
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Dry eye
Exclusion Criteria:
- unable to read consent
- investigator discretion
Sites / Locations
- Olympic OphthalmicsRecruiting
- Periman Eye InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapy Arm
Arm Description
Patient receive iTEAR100 treatment
Outcomes
Primary Outcome Measures
Schirmer score
Difference between Schirmer score measured before stimulation and after stimulation at each visit
Secondary Outcome Measures
Symptom Scores
Full Information
NCT ID
NCT05304637
First Posted
March 9, 2022
Last Updated
March 30, 2022
Sponsor
Olympic Ophthalmics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05304637
Brief Title
Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients
Official Title
Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympic Ophthalmics, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
iTEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed.
Detailed Description
TEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed. At both exam days, a Schirmer test before and after will be performed as well as parameters which indicate immediate effect of treatment and treatment over the 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open labe therapeutic study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapy Arm
Arm Type
Experimental
Arm Description
Patient receive iTEAR100 treatment
Intervention Type
Device
Intervention Name(s)
iTEAR100 treatment
Intervention Description
Vibratory energy to the external nasal nerve
Primary Outcome Measure Information:
Title
Schirmer score
Description
Difference between Schirmer score measured before stimulation and after stimulation at each visit
Time Frame
within 5 minutes of stimulation
Secondary Outcome Measure Information:
Title
Symptom Scores
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dry eye
Exclusion Criteria:
unable to read consent
investigator discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Gertner, MD
Phone
650-283-9388
Email
mgertner@oo-med.com
Facility Information:
Facility Name
Olympic Ophthalmics
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gertner
Phone
650-283-9388
Email
mgertner@oo-med.com
Facility Name
Periman Eye Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Periman, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients
We'll reach out to this number within 24 hrs