MicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye Syndrome
Conditions
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
Interventions
DEVICEiLIDS100
Subject applies iLIDS accessory to the iTEAR100 device. Applies to Eyelid margin similar to commercial products
Sponsors
Olympic Ophthalmics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label, Prospective, Therapeutic Intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire | 30 days | How does iLids compare to NuLids product |
Countries
United States
Contacts
Primary ContactMichael Gertner, MD
Outcome results
None listed