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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03097614
Recruitment Status : Completed
First Posted : March 31, 2017
Results First Posted : July 19, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Oculeve, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Dry Eye Syndromes Device: TrueTear Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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™
Actual Study Start Date : March 31, 2017
Actual Primary Completion Date : June 26, 2017
Actual Study Completion Date : June 26, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: TrueTear
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
 Device: TrueTear
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097614


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Oculeve, Inc.
Investigators
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Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
  Study Documents (Full-Text)

Documents provided by Oculeve, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] March 10, 2017

More Information
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Responsible Party: Oculeve, Inc.
ClinicalTrials.gov Identifier: NCT03097614    
Obsolete Identifiers: NCT03180047
Other Study ID Numbers: OCUN-029
First Posted: March 31, 2017    Key Record Dates
Results First Posted: July 19, 2018
Last Update Posted: October 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases