Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment

Oculeve

Status: Completed

Conditions: Dry Eye; Dry Eye Syndromes

Treatments: Device: TrueTear

Study type: Interventional

Funder types: Industry

Identifiers

NCT03097614

OCUN-029

Details and patient eligibility

About

This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.

Full description

Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.

Enrollment: 57 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
• Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
• Literate, able to speak English, and able to complete questionnaires independently

Exclusion criteria

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study
• Corneal transplant in either or both eyes
• Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
• A woman who is pregnant, nursing an infant, or planning a pregnancy during the duration of the study
• Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

TrueTear

Experimental group

Description:

The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Treatment:

Device: TrueTear