CClinicalTrials.gg
Status unknownNCT05304637Updated Mar 31, 2022

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

A Phase 4 interventional study of iTEAR100 treatment in Dry Eye, sponsored by Olympic Ophthalmics, Inc.. Status unknown at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Olympic Ophthalmics, Inc. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Olympic Ophthalmics, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Dry eye

Exclusion criteria

Exclusion Criteria:

  • unable to read consent
  • investigator discretion
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Therapy Arm

    Patient receive iTEAR100 treatment

    Device: iTEAR100 treatment

Interventions

  • DeviceiTEAR100 treatment

    Vibratory energy to the external nasal nerve

06

What researchers measure

Primary outcomes

  1. Schirmer score

    Difference between Schirmer score measured before stimulation and after stimulation at each visit

    Time frame: within 5 minutes of stimulation

Secondary outcomes

  1. Symptom Scores

    Time frame: 30 days

07

Study locations

2 of 2 sites recruiting
  • Olympic Ophthalmics
    Issaquah, Washington 98027, United States
    Recruiting
  • Periman Eye Institute
    Seattle, Washington 98119, United States
    • Laura Periman, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05304637
Lead sponsor
Olympic Ophthalmics, Inc.
Responsible party
Sponsor
First posted
Mar 31, 2022
Start date
Mar 1, 2022
Primary completion
Jun 1, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Mar 31, 2022

Study contacts

Michael Gertner, MD
Contact
mgertner@oo-med.com
650-283-9388

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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