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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04309799

Collaborator

(none)

Enrollment

Location

Arms

26.4

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Device: Tear Restore Mask	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 20, 2020

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Single 10 minute session 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 The Tear Restore Mask will be used for 10 minutes
Other: Optional Extension 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 The Tear Restore Mask will be used for 10 minutes

Arm

Intervention/Treatment

Other: Single 10 minute session

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

The Tear Restore Mask will be used for 10 minutes

Other: Optional Extension

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

The Tear Restore Mask will be used for 10 minutes

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado, Dept. of Ophthalmology	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Scott Hauswirth, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT04309799

Other Study ID Numbers:

18-1960

First Posted:

Mar 16, 2020

Last Update Posted:

Feb 17, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Colorado, Denver

Dry eye

Additional relevant MeSH terms:

Meibomian Gland Dysfunction

Study Results

No Results Posted as of Feb 17, 2022