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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05304637

Enrollment

Registered

2022-03-31

Start date

2022-03-01

Completion date

2022-07-01

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

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.

Interventions

DEVICEiTEAR100 treatment

Vibratory energy to the external nasal nerve

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open labe therapeutic study

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Dry eye

Exclusion criteria

* unable to read consent * investigator discretion

Design outcomes

Primary

Measure	Time frame	Description
Schirmer score	within 5 minutes of stimulation	Difference between Schirmer score measured before stimulation and after stimulation at each visit

Secondary

Measure	Time frame
Symptom Scores	30 days

Countries

United States

Contacts

Primary ContactMichael Gertner, MD

mgertner@oo-med.com650-283-9388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026