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Neuromodulation Device

Therapy Arm for Dry Eye Syndrome

Phase 4
Waitlist Available
Research Sponsored by Olympic Ophthalmics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Dry eye
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 5 minutes of stimulation
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial involves using the iTEAR generation 2 device to help with eye-related issues. Eligible patients will receive the device and be evaluated over a period of time. The study will measure changes in symptoms and tear production to assess the device's effectiveness. The iTEAR device is a novel, portable, sonic external neuromodulation device designed to treat dry eye disease (DED).

Eligible Conditions
  • Dry Eye Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 5 minutes of stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 5 minutes of stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Schirmer score

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Therapy ArmExperimental Treatment1 Intervention
Patient receive iTEAR100 treatment

Find a Location

Who is running the clinical trial?

Olympic Ophthalmics, Inc.Lead Sponsor
3 Previous Clinical Trials
335 Total Patients Enrolled
~8 spots leftby Dec 2025