NCT04763018

Brief Summary

Two study arms - sham and treatment; There will be a cross over of the sham group to the treatment group at day 15.

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
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 14, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 14, 2021

Last Update Submit

February 17, 2021

Conditions

Visual Display Users With Previously Undiagnosed Dry Eye

Outcome Measures

Primary Outcomes (3)

  • Meibomian Gland change in expressibility

    Change in gland expression from meibomian glands

    14 days

  • Corneal Staining

    Change in Staining of cornea

    14 days

  • Basal tear output

    Change in the basal output of tears

    14 days

Secondary Outcomes (1)

  • Safety

    30 days

Study Arms (2)

Treatment

ACTIVE COMPARATOR

This arm will receive a function iTEAR

Device: iTEAR100

Sham

SHAM COMPARATOR

This arm will receive sham treatment device

Device: iTEAR100

Interventions

iTEAR100DEVICE

Neurostimulation external nasal nerve to stimulate tear production

ShamTreatment

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 6hrs visual display terminal
  • OSDI \> 13
  • One of: SChirmer \< 10, One quadrant staining \> 2, or Meibomian Gland expression \<12

You may not qualify if:

  • Opinion of investigator that subject not be in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fishman Vision

Palo Alto, California, 94301, United States

RECRUITING

Central Study Contacts

Michael gertner, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Sham device produces noise but no stimulation energy. Assessor does not know which device the subject received. The subject does not know which device he or she received
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Day 14-30, all subjects receive therapy device
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2021

First Posted

February 21, 2021

Study Start

February 17, 2021

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

All results will be shared at conclusion of last follow up visit

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
December 2021

Locations

US(1)