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

Sponsor

Olympic Ophthalmics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05304637

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Device: iTEAR100 treatment	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open labe therapeutic studyOpen labe therapeutic study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapy Arm Patient receive iTEAR100 treatment	Device: iTEAR100 treatment Vibratory energy to the external nasal nerve

Arm

Intervention/Treatment

Experimental: Therapy Arm

Patient receive iTEAR100 treatment

Device: iTEAR100 treatment

Vibratory energy to the external nasal nerve

Outcome Measures

Primary Outcome Measures

Schirmer score [within 5 minutes of stimulation]
Difference between Schirmer score measured before stimulation and after stimulation at each visit

Secondary Outcome Measures

Symptom Scores [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Dry eye

Exclusion Criteria:

unable to read consent
investigator discretion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Olympic Ophthalmics	Issaquah	Washington	United States	98027
2	Periman Eye Institute	Seattle	Washington	United States	98119

Sponsors and Collaborators

Olympic Ophthalmics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Olympic Ophthalmics, Inc.

ClinicalTrials.gov Identifier:

NCT05304637

Other Study ID Numbers:

CLP-011

First Posted:

Mar 31, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Mar 31, 2022