A Usability Study of iTEAR100 For Combined EyeLid Microbl... | NCT06235450

Studies
A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

NCT06235450

Sponsor

Olympic Ophthalmics, Inc.

Status

Unknown status

Last Update Posted

Feb 1, 2024Actual

Enrollment

200Estimated

Phase

Phase 1

Conditions

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

Interventions

iLIDS100

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2024Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 23, 2024

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Feb 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2024

Last Update Posted Date

Feb 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This usability study is meant to validate treatment using the iLIDS100 in patients who already use the NuLids Device and iTEAR100. The patients will simply substitute the iLIDS100 cover in combination with the iTEAR100 for the NuLids product and otherwise maintain their same treatment regimen. The planned number of subjects was chosen to provide clinically relevant usability data

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Therapeutic iLIDS arm	Experimental	Subjects apply iTEAR100 device with iLIDS100 accessory	Device: iLIDS100

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iLIDS100	Device	Subject applies iLIDS accessory to the iTEAR100 device. Applies to Eyelid margin similar to commercial products	Therapeutic iLIDS arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Questionnaire	How does iLids compare to NuLids product	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must use iTEAR and NuLids at time of enrollment

Exclusion Criteria:

1. 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Gertner, MD	Contact	650-283-9388		mgertner@oo-med.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Olympic Ophthalmics	Recruiting	Issaquah	Washington	98027	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Full dataset , 30 days after study close

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

30 days after study completion

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001762	Blepharitis
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases
D007766	Lacrimal Apparatus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided