Back to resultsDry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment
Primary Purpose
Dry Eye, Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TrueTear
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility 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
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TrueTear
Arm Description
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Outcomes
Primary Outcome Measures
Eye Dryness Score
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03097614
Brief Title
Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment
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™
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
June 26, 2017 (Actual)
Study Completion Date
June 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculeve, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TrueTear
Arm Type
Experimental
Arm Description
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Intervention Type
Device
Intervention Name(s)
TrueTear
Intervention Description
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Primary Outcome Measure Information:
Title
Eye Dryness Score
Description
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.
Time Frame
Day 45
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment
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