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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-06-26

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dry Eye Dry Eye Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TrueTear

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

Group Type EXPERIMENTAL

TrueTear

Intervention Type DEVICE

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

Interventions

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TrueTear

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No