The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Meibomian Gland Function
NCT ID: NCT04309799
Last Updated: 2022-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-11-20
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Tear Restore Mask
The Tear Restore Mask will be used for 10 minutes
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.
Tear Restore Mask
The Tear Restore Mask will be used for 10 minutes
Interventions
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Tear Restore Mask
The Tear Restore Mask will be used for 10 minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosed with a systemic autoimmune condition including but not limited to Sjogren's or Lupus
18 Years
89 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Scott Hauswirth, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado, Dept. of Ophthalmology
Aurora, Colorado, United States
Countries
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Other Identifiers
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18-1960
Identifier Type: -
Identifier Source: org_study_id
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