Recruiting
Phase 1

iTEAR100

Sponsor:

Olympic Ophthalmics, Inc.

Code:

NCT06235450

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

iLIDS100

Study Details

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.

Conditions

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

Study ID

NCT06235450

Start date

Jan 19, 2024

Status verified date

Jan, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Therapeutic iLIDS arm

Subjects apply iTEAR100 device with iLIDS100 accessory

Interventions

iLIDS100

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

Primary outcome measure

  • Questionnaire [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Michael Gertner, MD

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

Locations

Olympic Ophthalmics

Recruiting

Issaquah, Washington, United States, 98027

Contacts

Michael Gertner, MD

650-283-9388

Michael Gertner, MD

6502839388mgertner@oo-med.com

Principal Investigator:

Michael Gertner, MD

More Information

Sponsor

Olympic Ophthalmics, Inc.

Last update posted

Feb 1, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Olympic Ophthalmics, Inc. on 2024-02-01.