Pilot Study of TearCare System - Long-Term Extension

Study Overview
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Brief Summary
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The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.

Official Title
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Pilot Study of TearCare System - Long-Term Extension

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: TearCare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously enrolled in the TearCare arm of the TearCare Pilot Study Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6 TBUT of <10 seconds in at least one eye Willing to comply with the study, procedures, and follow-up Willing and able to provide consent Exclusion Criteria: Any active ocular or peri-ocular infection or inflammation Recurrent eye inflammation within the past 3 months Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster Ocular surface abnormalities that may affect tear film distribution or treatment Abnormal eyelid function in either eye Diminished or abnormal facial, periocular, ocular or corneal sensation Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome) Allergies to silicone tissue adhesives An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia). Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.) Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days. Unwillingness to washout and remain off certain dry eye medications for the duration of the study. Participation in another ophthalmic clinical trial within the past 30 days Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)

Ages Eligible for Study
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Minimum Age: 18 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>Subjects will receive one TearCare treatment at the baseline visit | Device: TearCare<br>* The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break-Up Time | Tear Break-Up Time measures the time (in seconds) to the first observation of breakup of the tear film. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibomian Gland Secretion Score | This is a measure of the quality of secretions from the meibomian glands. Each gland is score from 0-3; 15 glands of each lower eyelid are scored. Range of the score is 0-45. | 1 month | 
| SPEED II Questionnaire | The Standard Patient Evaluation of Dry Eye (SPEED) measures the severity and frequency of dry eye symptoms. | 1 month | 
| OSDI Questionnaire | The Ocular Surface Disease Index (OSDI) questionnaire assesses the ocular symptoms, impact on patient vision-related functioning, and environmental factors triggering the symptoms. | 1 month | 
| Corneal staining | This measures the degree of staining on the surface of the cornea using the NEI scale. | 1 month | 
| Conjunctival staining | This measures the degree of staining on the surface of the conjunctival using the NEI scale. | 1 month | 
| Adverse Events | All device-related and ocular adverse events will be collected. | 1 month |