NCT06235450

A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Olympic Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	iLIDS100	Subject applies iLIDS accessory to the iTEAR100 device. Applies to Eyelid margin similar to commercial products

Timeline

• Start date: 2024-01-19
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-02-01
• Last updated: 2024-02-01

Locations

1 site across 1 country: United States