The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Meibomian Gland Function
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 16, 2020
CompletedStudy Start
First participant enrolled
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedFebruary 17, 2022
February 1, 2022
2.2 years
March 12, 2020
February 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Lipid Layer Thickness
Up to 60 days
Tear Breakup Time
Up to 60 days
Number of Meibomian Glands Yielding Liquid Secretions
Up to 60 days
Study Arms (2)
Single 10 minute session
OTHERStudy 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
OTHERSubjects 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.
Interventions
The Tear Restore Mask will be used for 10 minutes
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado, Dept. of Ophthalmology
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Hauswirth, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 16, 2020
Study Start
November 20, 2020
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
February 17, 2022
Record last verified: 2022-02