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

NCT ID: NCT05304637

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open labe therapeutic study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapy Arm

Patient receive iTEAR100 treatment

Group Type EXPERIMENTAL

iTEAR100 treatment

Intervention Type DEVICE

Vibratory energy to the external nasal nerve

Interventions

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iTEAR100 treatment

Vibratory energy to the external nasal nerve

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Dry eye

Exclusion Criteria

* unable to read consent
* investigator discretion
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olympic Ophthalmics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Olympic Ophthalmics

Issaquah, Washington, United States

Site Status RECRUITING

Periman Eye Institute

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Gertner, MD

Role: CONTACT

Phone: 650-283-9388

Email: [email protected]

Facility Contacts

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Michael Gertner

Role: primary

Laura Periman, MD

Role: primary

Other Identifiers

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CLP-011

Identifier Type: -

Identifier Source: org_study_id