A Usability Study of External Neuromodulation With iTEAR100 Generation 2
- Conditions
- Dry Eye Syndromes
- Interventions
- Device: iTEAR100
- Registration Number
- NCT05304650
- Lead Sponsor
- Olympic Ophthalmics, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Able to sign English language consent form and over age 18 and reside in the U.S.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description iTEAR100 Therapy iTEAR100 Treatment Arm. Assessment of usability of generation 2 connected devices
- Primary Outcome Measures
Name Time Method Usability 30 days Subjects rate the device usability similar to daily mobile applications and home devices using a scale from -3 to +3 with 0 being same as every day devices such as bank application, restaurant application, etc.
- Secondary Outcome Measures
Name Time Method Adverse Events 30 days Skin Damage, Headache, Dizziness, Sneezing
Symptom Score 30 Days SPEED standard symptom score
Symptom Scores 30 days OSDI and SPEED standard symptom scores
Trial Locations
- Locations (1)
Olympic Ophthalmics
🇺🇸Issaquah, Washington, United States