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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04309799
• Other study ID #: 18-1960
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: February 2023

Study information

• Verified date: February 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Device:
• Tear Restore Mask
The Tear Restore Mask will be used for 10 minutes

Locations

Country	Name	City	State
United States	University of Colorado, Dept. of Ophthalmology	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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