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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
Olympic Ophthalmics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 9, 2022
Last Updated
March 30, 2022
Sponsor
Olympic Ophthalmics, Inc.
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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

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