Back to resultsRandomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease
Primary Purpose
Dry Eye Syndromes
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TearCare
Warm Compress and Lid Massage
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with dry eye disease
- Signs and symptoms of dry eye disease
- Best corrected visual acuity 20/100 or better
- Willing and able to comply with study procedures
- Willing and able to provide consent
Exclusion Criteria:
- Active ocular infection or inflammation
- History of eyelid, conjunctiva or corneal surgery within the past year.
- Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
- Contact lens wearer
- Significant ocular surface or eyelid abnormalities, recent ocular trauma
- Certain corneal surface abnormalities
- Use of medications for treatment of dry eye or medications that cause dry eye
- Systemic disease that results in dry eye
Sites / Locations
- Harvard Eye Associates
- Eye Research Foundation
- Center for Excellence in Eye Care
- Cincinnati Eye Institute
- Ophthalmology Associates
- Vance Thompson Vision
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TearCare
Warm Compress & Lid Massage
Arm Description
TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands.
Subjects will perform warm compress and lid massage at home daily.
Outcomes
Primary Outcome Measures
Tear Break-Up Time
Secondary Outcome Measures
Ocular Surface Disease Index (OSDI)
This is a questionnaire that measures the severity of symptoms of dry eye disease.
Meibomian Gland Score
The Meibomian Gland Secretion Scoring is an assessment of the quality of the secretions produced by the meibomian glands in the lower eyelids. Fifteen glands in each lower eyelid are scored. The Score is calculated by summing the grade (0 - 3) for each of the 15 glands. Range for this score is 0-45, with 45 being the best and 0 being the worst.
Corneal and conjunctival staining graded using the NEI/Industry Grading System.
For corneal staining, the assessor scores 5 areas of the cornea (grade 0-3) and sums the grade for each area to obtain the total score. The score ranges from 0-15 with 0 being the best and 15 being the worst.
For conjunctival staining, the assessor scores 6 areas of the conjunctiva (grade 0-3) and sums the grade for each area to obtain the total score. The score ranges from 0-18 with 0 being the best and 18 being the worst.
Symptom Assessment in Dry Eye (SANDE) and Eye Dryness Visual Analog Scale (VAS)
The SANDE is a simple dry eye instrument containing two items measuring the frequency and severity of symptoms, each is assessed on a 100 mm visual analog scale. The Eye Dryness (VAS) measures the level of discomfort associated with eye dryness on a 100mm VAS. The score for each question is calculated by measuring the distance from the left end of the line to the subject's response (range 0-100).
For these scales, a lower score is better than a higher score.
Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03502447
Brief Title
Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease
Official Title
Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor chose to change the study design.
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
January 2, 2019 (Actual)
Study Completion Date
January 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sight Sciences, 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
In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage.
NOTE: All sites have been selected for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TearCare
Arm Type
Experimental
Arm Description
TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands.
Arm Title
Warm Compress & Lid Massage
Arm Type
Active Comparator
Arm Description
Subjects will perform warm compress and lid massage at home daily.
Intervention Type
Device
Intervention Name(s)
TearCare
Intervention Description
TearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands.
Intervention Type
Device
Intervention Name(s)
Warm Compress and Lid Massage
Intervention Description
Subjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage.
Primary Outcome Measure Information:
Title
Tear Break-Up Time
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI)
Description
This is a questionnaire that measures the severity of symptoms of dry eye disease.
Time Frame
1 month
Title
Meibomian Gland Score
Description
The Meibomian Gland Secretion Scoring is an assessment of the quality of the secretions produced by the meibomian glands in the lower eyelids. Fifteen glands in each lower eyelid are scored. The Score is calculated by summing the grade (0 - 3) for each of the 15 glands. Range for this score is 0-45, with 45 being the best and 0 being the worst.
Time Frame
1 month
Title
Corneal and conjunctival staining graded using the NEI/Industry Grading System.
Description
For corneal staining, the assessor scores 5 areas of the cornea (grade 0-3) and sums the grade for each area to obtain the total score. The score ranges from 0-15 with 0 being the best and 15 being the worst.
For conjunctival staining, the assessor scores 6 areas of the conjunctiva (grade 0-3) and sums the grade for each area to obtain the total score. The score ranges from 0-18 with 0 being the best and 18 being the worst.
Time Frame
1 month
Title
Symptom Assessment in Dry Eye (SANDE) and Eye Dryness Visual Analog Scale (VAS)
Description
The SANDE is a simple dry eye instrument containing two items measuring the frequency and severity of symptoms, each is assessed on a 100 mm visual analog scale. The Eye Dryness (VAS) measures the level of discomfort associated with eye dryness on a 100mm VAS. The score for each question is calculated by measuring the distance from the left end of the line to the subject's response (range 0-100).
For these scales, a lower score is better than a higher score.
Time Frame
1 month
Title
Adverse Events
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with dry eye disease
Signs and symptoms of dry eye disease
Best corrected visual acuity 20/100 or better
Willing and able to comply with study procedures
Willing and able to provide consent
Exclusion Criteria:
Active ocular infection or inflammation
History of eyelid, conjunctiva or corneal surgery within the past year.
Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
Contact lens wearer
Significant ocular surface or eyelid abnormalities, recent ocular trauma
Certain corneal surface abnormalities
Use of medications for treatment of dry eye or medications that cause dry eye
Systemic disease that results in dry eye
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Cincinnati Eye Institute
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease
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