NCT05304637

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

March 9, 2022

Last Update Submit

March 30, 2022

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Schirmer score

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

    within 5 minutes of stimulation

Secondary Outcomes (1)

  • Symptom Scores

    30 days

Study Arms (1)

Therapy Arm

EXPERIMENTAL

Patient receive iTEAR100 treatment

Device: iTEAR100 treatment

Interventions

iTEAR100 treatmentDEVICE

Vibratory energy to the external nasal nerve

Therapy Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry eye

You may not qualify if:

  • unable to read consent
  • investigator discretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Olympic Ophthalmics

Issaquah, Washington, 98027, United States

RECRUITING

Periman Eye Institute

Seattle, Washington, 98119, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Michael Gertner, MD

CONTACT

650-283-9388mgertner@oo-med.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open labe therapeutic study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 31, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)