NCT06235450

Brief Summary

The purpose of this study is to evaluate the usability of the iTEAR100 generation 2 device in combination with its newly developed iLIDS100 disposable cover.

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
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2024

Typical duration for phase_1

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

Study Start

First participant enrolled

January 19, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 23, 2024

Last Update Submit

January 23, 2024

Conditions

MicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

    How does iLids compare to NuLids product

    30 days

Study Arms (1)

Therapeutic iLIDS arm

EXPERIMENTAL

Subjects apply iTEAR100 device with iLIDS100 accessory

Device: iLIDS100

Interventions

iLIDS100DEVICE

Subject applies iLIDS accessory to the iTEAR100 device. Applies to Eyelid margin similar to commercial products

Therapeutic iLIDS arm

Eligibility Criteria

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

You may qualify if:

  • Must use iTEAR and NuLids at time of enrollment

You may not qualify if:

  • \. have any condition, which in the judgment of the PI would prevent a potential subject from safely completing the study or tolerating device use, such as mental illness, dementia, severe agitation, etc. and including inability to comply with the treatment regimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olympic Ophthalmics

Issaquah, Washington, 98027, United States

RECRUITING

MeSH Terms

Conditions

BlepharitisDry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesLacrimal Apparatus Diseases

Central Study Contacts

Michael Gertner, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open Label, Prospective, Therapeutic Intervention
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 1, 2024

Study Start

January 19, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Full dataset , 30 days after study close

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
30 days after study completion

Locations

US(1)