A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation
Phase 1
Recruiting
- Conditions
- MicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye Syndrome
- Interventions
- Device: iLIDS100
- Registration Number
- NCT06235450
- Lead Sponsor
- Olympic Ophthalmics, Inc.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Must use iTEAR and NuLids at time of enrollment
Exclusion Criteria
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Therapeutic iLIDS arm iLIDS100 Subjects apply iTEAR100 device with iLIDS100 accessory
- Primary Outcome Measures
Name Time Method Questionnaire 30 days How does iLids compare to NuLids product
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Olympic Ophthalmics
🇺🇸Issaquah, Washington, United States