Back to resultsA Usability Study of External Neuromodulation With iTEAR100 Generation 2
Primary Purpose
Dry Eye Syndromes
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
iTEAR100
Sponsored by
About this trial
This is an interventional other trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria: Able to sign English language consent form and over age 18 and reside in the U.S.
-
Exclusion Criteria:
-
Sites / Locations
- Olympic OphthalmicsRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
iTEAR100 Therapy
Arm Description
Treatment Arm. Assessment of usability of generation 2 connected devices
Outcomes
Primary Outcome Measures
Usability
Subjects rate the device usability similar to daily mobile applications and home devices using a scale from -3 to +3 with 0 being same as every day devices such as bank application, restaurant application, etc.
Secondary Outcome Measures
Symptom Scores
OSDI and SPEED standard symptom scores
Adverse Events
Skin Damage, Headache, Dizziness, Sneezing
Symptom Score
SPEED standard symptom score
Full Information
NCT ID
NCT05304650
First Posted
March 1, 2022
Last Updated
March 30, 2022
Sponsor
Olympic Ophthalmics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05304650
Brief Title
A Usability Study of External Neuromodulation With iTEAR100 Generation 2
Official Title
A Usability Study of External Neuromodulation With iTEAR100 Generation 2
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
April 30, 2022 (Anticipated)
Study Completion Date
June 15, 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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment.
Detailed Description
A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment. Subjects sign a consent form and are sent a device. After downloading a mobile app, they can access the device and download a prescription. At 7 days, an official telehealth visit evaluates their success in the set up and training. At 30 days, the trial ends, A usability survey and symptom evaluation survey are used to determine success.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open Label Study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iTEAR100 Therapy
Arm Type
Other
Arm Description
Treatment Arm. Assessment of usability of generation 2 connected devices
Intervention Type
Device
Intervention Name(s)
iTEAR100
Intervention Description
Controlled Stimulation External Nasal Nerve to stimulate tear production
Primary Outcome Measure Information:
Title
Usability
Description
Subjects rate the device usability similar to daily mobile applications and home devices using a scale from -3 to +3 with 0 being same as every day devices such as bank application, restaurant application, etc.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Symptom Scores
Description
OSDI and SPEED standard symptom scores
Time Frame
30 days
Title
Adverse Events
Description
Skin Damage, Headache, Dizziness, Sneezing
Time Frame
30 days
Title
Symptom Score
Description
SPEED standard symptom score
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to sign English language consent form and over age 18 and reside in the U.S.
-
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Gertner
Phone
650-300-9340
Email
clinicaltrials@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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Usability Study of External Neuromodulation With iTEAR100 Generation 2
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