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

Olympic Ophthalmics

Status and phase: Unknown; Phase 4

Conditions: Dry Eye

Treatments: Device: iTEAR100 treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05304637

CLP-011

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dry eye

Exclusion criteria

• unable to read consent
• investigator discretion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Therapy Arm

Experimental group

Description:

Patient receive iTEAR100 treatment

Treatment:

Device: iTEAR100 treatment