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

Not Applicable

• Conditions: Meibomian Gland Dysfunction
• Interventions: Device: Tear Restore Mask

• Registration Number: NCT04309799
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-16
• Study Start: 2020-11-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-17
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single 10 minute session	Tear Restore Mask	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.
Optional Extension	Tear Restore Mask	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Lipid Layer Thickness	Up to 60 days	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.
Tear Breakup Time	Up to 60 days	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.
Number of Meibomian Glands Yielding Liquid Secretions	Up to 60 days	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.

Trial Locations

Locations (1)

University of Colorado, Dept. of Ophthalmology; 🇺🇸 Aurora, Colorado, United States