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

University of Colorado Denver (CU Denver)

Status: Unknown

Conditions: Meibomian Gland Dysfunction

Treatments: Device: Tear Restore Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04309799

18-1960

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Single 10 minute session

Other group

Description:

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.

Treatment:

Device: Tear Restore Mask

Optional Extension

Other group

Description:

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.

Treatment:

Device: Tear Restore Mask