Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TearRestore
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04309799
Recruitment Status : Not yet recruiting
First Posted : March 16, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of Meibomian Glands Yielding Liquid Secretions [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309799


Contacts
Layout table for location contacts
Contact: Rachel Gerle 720-848-5096 rachel.gerle@cuanschutz.edu

Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Scott Hauswirth, MD University of Colorado, Denver
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04309799    
Other Study ID Numbers: 18-1960
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020

Layout table for additional information
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
Keywords provided by University of Colorado, Denver:
Dry eye