Study of the TearCare System in Dry Eye Disease

Study Overview
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Brief Summary
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This study is being conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease. NOTE: All sites have been selected for this study.

Official Title
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Study of the TearCare System in Dry Eye Disease

Conditions
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Dry Eye

Intervention / Treatment
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* Device: TearCare


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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TearCare<br>All subjects in the study will undergo the TearCare procedure one time at the baseline visit. They will then be followed out to one month. | Device: TearCare<br>* The TearCare procedure includes the delivery of thermal energy to the external surface of the eyelids for 15 minutes, immediately followed by manual expression of each eyelid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tear Break-up time from baseline to 1 month | Tear Break-up Time is defined as the number of seconds between a blink and the appearance of a first dry spot or negative staining in the tear film. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular Surface Disease Index (OSDI) score from baseline to 1 month | The OSDI is a questionnaire that assesses the symptoms of dry eye disease | 1 month | 
| Change in Meibomian gland secretion score from baseline to 1 month | The is a measure of the quality of the secretions from the meibomian glands | 1 month | 
| Change in Cornea staining score from baseline to 1 month | This is a measure of the degree of staining on the cornea. | 1 month | 
| Change in Conjunctival staining score from baseline to 1 month | This is a measure of the degree of staining on the conjunctiva | 1 month | 
| Device-related adverse events | Any untoward adverse event that is attributed to the study device | 1 month | 
| Change in best spectacle-corrected visual acuity from baseline to 1 month |  | 1 month |