Usability evaluation of the iTEAR100 device with a new cover for eye treatment
A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation
PHASE1 · Olympic Ophthalmics, Inc. · NCT06235450
This study is testing a new cover for the iTEAR100 device to see if it makes eye treatment easier for people who are already using it.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Olympic Ophthalmics, Inc. (industry) |
| Locations | 1 site (Issaquah, Washington) |
| Trial ID | NCT06235450 on ClinicalTrials.gov |
What this trial studies
This study evaluates the usability of the iTEAR100 generation 2 device when used with the newly developed iLIDS100 disposable cover. Participants who are already using the NuLids Device and iTEAR100 will replace their current cover with the iLIDS100 while maintaining their existing treatment regimen. The study aims to gather clinically relevant usability data from a planned number of subjects to validate this new combination treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients currently using the iTEAR100 and NuLids devices.
Not a fit: Patients with conditions that prevent safe device use or compliance with the treatment regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness and user experience of eye treatment devices for patients with dry eye syndrome and related conditions.
How similar studies have performed: While this approach is innovative, it builds on existing treatments, and similar studies have shown promise in enhancing usability and effectiveness of eye care devices.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Issaquah, Washington
- Olympic Ophthalmics — Issaquah, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Michael Gertner, MD
- Email: mgertner@oo-med.com
- Phone: 650-283-9388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye Syndrome