TearCare System to Treat 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 the LipiFlow Thermal Pulsation System 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. NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.

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, Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: TearCare
* Device: LipiFlow


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: At least 22 Subject has dry eye symptoms and uses artificial tears/lubricants regularly Subject has moderate to severe symptoms based on a dry eye questionnaire Subject has an abnormal tear break-up time Subject's eyelid glands secrete a low amount of meibum Best corrected visual acuity 20/100 or better Willing and able to comply with protocol Willing and able to provide consent English-speaking Key Exclusion Criteria: Use of medications that treat dry eye disease or that are known to cause ocular dryness. Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing. History of eyelid, conjunctival or corneal surgery within the past year. Contact lens use within past 2 weeks Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TearCare<br>Subjects will have heat applied to the eyelids for 15 minutes followed by manual expression of the meibomian glands. | Device: TearCare<br>* The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.<br>|
| Active Comparator: LipiFlow<br>Subjects will have heat and pressure applied to the eyelids for 12 minutes. | Device: LipiFlow<br>* The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.<br>* Other names: Thermal Pulsation;|

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 is the time measured to the first observation of a break in the tear film | 1 month | 
| Meibomian Gland Secretion Score | The Meibomian Gland Secretion score is the measure of the quality of the secretions in the meibomian glands. Secretions are scored on a scale from 0-3, with 0 indicating no secretion and 3 indicating clear secretions. Fifteen glands are scored in each lower eyelid. Total score ranges from 0-45. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index (OSDI) | The OSDI is a questionnaire that measures the severity of symptoms of dry eye disease. Total score can range from 0-100. A score of 0-12 is normal, 13-22 is mild, 23-32 is moderate, and 33-100 is severe dry eye. | 1 month | 
| Corneal staining score | This scores the amount of staining observed on the surface of the cornea using the NEI Scale. Five regions of the cornea are scored on a scale from 0-3, with 0 being no staining and 3 being the most staining. The total score can range from 0-15. | 1 month | 
| Conjunctival staining score | This scores the amount of staining observed on the surface of the conjunctiva using the NEI scale. Six regions of the conjunctiva are scored on a scale from 0-3, with 0 being no staining and 3 being the most staining. The total score can range from 0-18. | 1 month | 
| SANDE | Symptom Assessment iN Dry Eye (SANDE) questionnaire is a visual analog scale the measures the severity and frequency of dry eye symptoms. The scale ranges from 0 to 100 with 0 being the least and 100 being the worst. | 1 month | 
| Eye Dryness Score | Eye Dryness Score is a visual analog scale the measures the level of discomfort related to eye dryness. The scale ranges from 0 to 100 with 0 being the least and 100 being the worst. | 1 month | 
| Meibomian glands yielding clear secretions | This is a count of the number of glands scored as having clear secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best. | 1 month | 
| Meibomian glands yielding clear or cloudy secretions | This is a count of the glands scored as having clear or cloudy secretions. Fifteen glands are scored. Total score ranges from 0-15 with 15 being the best.. | 1 month |