NCT05304650

A Usability Study of External Neuromodulation With iTEAR100 Generation 2

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Olympic Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment.

Detailed description

A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment. Subjects sign a consent form and are sent a device. After downloading a mobile app, they can access the device and download a prescription. At 7 days, an official telehealth visit evaluates their success in the set up and training. At 30 days, the trial ends, A usability survey and symptom evaluation survey are used to determine success.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	iTEAR100	Controlled Stimulation External Nasal Nerve to stimulate tear production

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-04-30
• Completion: 2022-06-15
• First posted: 2022-03-31
• Last updated: 2022-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study