- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309799
The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Meibomian Gland Function
February 16, 2022 updated by: University of Colorado, Denver
The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Symptoms and Signs of Meibomian Gland Function
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado, Dept. of Ophthalmology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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The Tear Restore Mask will be used for 10 minutes
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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.
|
The Tear Restore Mask will be used for 10 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Time Frame: 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
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Up to 60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid Layer Thickness
Time Frame: 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.
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Up to 60 days
|
Tear Breakup Time
Time Frame: 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.
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Up to 60 days
|
Number of Meibomian Glands Yielding Liquid Secretions
Time Frame: Up to 60 days
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Scott Hauswirth, MD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2020
Primary Completion (Anticipated)
February 1, 2023
Study Completion (Anticipated)
February 1, 2023
Study Registration Dates
First Submitted
March 12, 2020
First Submitted That Met QC Criteria
March 13, 2020
First Posted (Actual)
March 16, 2020
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 16, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-1960
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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