Dry Eye Syndromes
Conditions
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.
Interventions
DEVICEiTEAR100
Controlled Stimulation External Nasal Nerve to stimulate tear production
Sponsors
Olympic Ophthalmics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open Label Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Able to sign English language consent form and over age 18 and reside in the U.S. \-
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Symptom Score | 30 Days | SPEED standard symptom score |
| Symptom Scores | 30 days | OSDI and SPEED standard symptom scores |
| Adverse Events | 30 days | Skin Damage, Headache, Dizziness, Sneezing |
Countries
United States
Contacts
Primary ContactMichael Gertner
Outcome results
None listed