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

Not Applicable

Completed

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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Eye Dryness Score	Day 45	Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm.

Secondary Outcome Measures