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

Phase 4

• Conditions: Dry Eye

• Registration Number: NCT05304637
• Lead Sponsor: Olympic Ophthalmics, Inc.

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.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-30
• Last Update Submitted: 2022-03-30
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Dry eye

Exclusion Criteria

• unable to read consent
• investigator discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Schirmer score	within 5 minutes of stimulation	Difference between Schirmer score measured before stimulation and after stimulation at each visit

Secondary Outcome Measures

Name	Time	Method
Symptom Scores	30 days

Trial Locations

Locations (2)

Olympic Ophthalmics; 🇺🇸 Issaquah, Washington, United States

Periman Eye Institute; 🇺🇸 Seattle, Washington, United States