Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: TearCare
* Device: Warm Compress and Lid Massage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TearCare<br>TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands. | Device: TearCare<br>* 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.<br>|
| Active Comparator: Warm Compress & Lid Massage<br>Subjects will perform warm compress and lid massage at home daily. | Device: Warm Compress and Lid Massage<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break-Up Time |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index (OSDI) | This is a questionnaire that measures the severity of symptoms of dry eye disease. | 1 month | 
| 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. | 1 month | 
| 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. | 1 month | 
| 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. | 1 month | 
| Adverse Events |  | 1 month |