A Phase 1 interventional study of iLIDS100 in MicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye Syndrome, sponsored by Olympic Ophthalmics, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by Olympic Ophthalmics, Inc. · Phase 1, Interventional, and Treatment
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.
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
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Olympic Ophthalmics, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Must use iTEAR and NuLids at time of enrollment
Exclusion Criteria:
Subjects apply iTEAR100 device with iLIDS100 accessory
Device: iLIDS100
Subject applies iLIDS accessory to the iTEAR100 device. Applies to Eyelid margin similar to commercial products
Questionnaire
How does iLids compare to NuLids product
Time frame: 30 days
Plan to share: Yes — Full dataset , 30 days after study close
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 30 days after study completion
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Olympic Ophthalmics, Inc.