Pilot Study of the TearCare System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical utility, safety, and effectiveness of the TearCare™ System compared to standardized warm compress therapy for the application of controlled, localized heat therapy in adult patients with dry eye syndrome.

Official Title
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Pilot Study of the TearCare System

Conditions
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Dry Eye

Intervention / Treatment
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* Device: TearCare
* Device: Warm Compress


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dry eye symptoms within 30 months of the screening exam with a SPEED score >=6 Schirmer 1 value of <010 mm in at least one eye or a Tear Breakup time <10 seconds in at least one eye 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TearCare<br>Subjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands. | Device: TearCare<br> <br> |
| Active Comparator: Warm Compress<br>Subjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks. | Device: Warm Compress<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Breakup Time |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibomian Gland Assessment |  | Day 1, Week 2, Week 4, 3 Month, 6 Month | 
| Dry Eye Symptoms and Quality of Life |  | Week 2, Week 4, 3 Month, 6 Month | 
| Change in Medication Use |  | Day 1, Week 2, Week 4, 3 Month, 6 Month | 
| Adverse Events |  | Day 0, Day 1, Week 2, Week 4, 3 Month, 6 Month |