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Completed

NCT Number: NCT03097614

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

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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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TrueTear

Device

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

Primary outcomes

  1. Eye Dryness Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oculeve, Inc.

Industry

Registry information

Official study title

Prospective, Single-Arm Clinical Trial to Evaluate Acute Dry Eye Symptom Relief Assessed During Exposure to a Controlled Adverse Environment (CAE®) Following a 45 Day Period With Application of TrueTear™

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2017
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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