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NCT05304637 Clinical Trial

Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients

Dry Eye Clinical Trial

Official title:
Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05304637
Other study ID # CLP-011
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2022
Est. completion date July 1, 2022

Study information
Verified date March 2022
Source Olympic Ophthalmics, Inc.
Contact Michael Gertner, MD
Phone 650-283-9388
Email mgertner@oo-med.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

iTEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date July 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Dry eye Exclusion Criteria: - unable to read consent - investigator discretion

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• iTEAR100 treatment
Vibratory energy to the external nasal nerve

Locations
Country Name City State
United States Olympic Ophthalmics Issaquah Washington
United States Periman Eye Institute Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Olympic Ophthalmics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Schirmer score Difference between Schirmer score measured before stimulation and after stimulation at each visit within 5 minutes of stimulation
Secondary Symptom Scores 30 days
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