A Usability Study of External Neuromodulation With iTEAR100 Generation 2

Olympic Ophthalmics

Status and phase: Unknown; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Device: iTEAR100

Study type: Interventional

Funder types: Industry

Identifiers

NCT05304650

clp 010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Able to sign English language consent form and over age 18 and reside in the U.S.

Exclusion Criteria:

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

iTEAR100 Therapy

Other group

Description:

Treatment Arm. Assessment of usability of generation 2 connected devices

Treatment:

Device: iTEAR100