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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 5 minutes of stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 5 minutes of stimulation
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
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Who is running the clinical trial?
Olympic Ophthalmics, Inc.Lead Sponsor
3 Previous Clinical Trials
335 Total Patients Enrolled
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