The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Meibomian Gland Function

Study Overview
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Brief Summary
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This study plans to learn more about the effectiveness of the TearRestore eyelid warming mask on signs and symptoms of Meibomian Gland Dysfunction (MGD). MGD is a leading cause of dry eye symptoms. Warm compresses are a standard treatment recommended by physicians to treat those diagnosed with MGD. The study will investigate whether the TearRestore mask affects meibomian gland function and dry eye symptoms.

Detailed Description
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The study will evaluate the effectiveness of the TearRestore eyelid warming mask on signs and symptoms of MGD. Warm compress treatments have been recommended as part of the standard of care by eye physicians, and are an important means in treating MGD. However, current treatment options suffer from varied temperature maintenance and poor compliance. The TearRestore™ mask offers patients a unique experience through providing sustained heat and the ability to see throughout the treatment, which will improve efficacy through improved compliance. If shown to be effective in altering Meibomian gland secretions at a single visit, this novel treatment could potentially offer the millions of patients suffering from MGD a more convenient and effective way to treat the condition.

Official Title
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The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Symptoms and Signs of Meibomian Gland Function

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: Tear Restore Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants (age 18-89) of any race, gender or ethnicity, diagnosed with meibomian gland dysfunction Symptom score greater than eight on the SPEED questionnaire Less than 75nm lipid layer thickness (LLT) utilizing the Lipiview II Less than 10 second tear break up time (average of 3 measurements) Exclusion Criteria: Participants with less than 6/15 meibomian glands yielding liquid secretions in either eyelid Diagnosed with a systemic autoimmune condition including but not limited to Sjogren's or Lupus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single 10 minute session<br>Study assessments will be performed before single 10 minute session of wearing the Tear Restore Mask and then study assessments will be repeated after the 10 minute single session has been completed. | Device: Tear Restore Mask<br>* The Tear Restore Mask will be used for 10 minutes<br>|
| Other: Optional Extension<br>Subjects can choose to extend use of the Tear Restore Mask at home for a period of 28 to 60 days. They will use the mask for a 10 minute time period one time per day and record the use in a diary. | Device: Tear Restore Mask<br>* The Tear Restore Mask will be used for 10 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire | The SPEED questionnaire will be completed by the subject prior to using the Tear Restore Mask and then repeated after the 10 minute session | Up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Layer Thickness | The Lipid Layer Thickness will be measured prior to using the Tear Restore Mask using the Lipiview II machine and then repeated following the 10 minute session. | Up to 60 days | 
| Tear Breakup Time | The Tear Breakup Time will be measured prior to using the Tear Restore Mask by the Clinician and then repeated following to 10 minute session. | Up to 60 days | 
| Number of Meibomian Glands Yielding Liquid Secretions | The Number of Meibomian Glands Yielding Liquid Secretions will be counted by the clinician prior to using the Tear Restore Mask and then recounted by the clinician following to 10 minute session. | Up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye