Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction

March 15, 2018 updated by: UMay Care Inc.

PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction

The purpose of this pilot study is to determine the feasibility of at home thermal therapy with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.

This will be done by assessing patients for improvement in symptoms and ocular oil gland function after 4 weeks of a daily thermal therapy application.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will be a non-randomized, open label study of subjects with documented MGD. All subjects will be sent home with a wireless, portable thermal therapy device and examined pre and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and symptomatic change in their MGD as well as changes to their sleep quality and anxiety index. Subjects will also be followed after treatment has been completed.

Study Type

Interventional

Enrollment (Anticipated)

20

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.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of MGD
  • Minimum age 18 years

Exclusion Criteria:

  • History of ocular disease, trauma, surgery (other than refractive), orbital cancer
  • 3 month history of ocular infection and/or ocular inflammation not associated with dry eye
  • 3 month history of any active physician administered or prescription dry eye treatment
  • Pregnant, potentially pregnant or nursing

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thermal Therapy
Heat application using at home thermal therapy device
Device: Thermal therapy device
Thermal therapy of blocked Meibomian glands
Other Names:
  • umayREST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
Time Frame: Before and after 4 weeks of daily treatment
Ocular surface analysis of tear film evaporation
Before and after 4 weeks of daily treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ocular Surface Disease Index (OSDI) Score
Time Frame: Before and after 4 weeks of daily treatment
Standardized symptom questionnaire
Before and after 4 weeks of daily treatment
Meibum Expressibility
Time Frame: Before and after 4 weeks of daily treatment
Grade of Meibum oil expressibility from Meibomian Gland
Before and after 4 weeks of daily treatment
Sleep Quality
Time Frame: Before and after 4 weeks of daily treatment
Pittsburg Sleep Quality Index (PSQI)
Before and after 4 weeks of daily treatment
State Trait and Anxiety
Time Frame: Before and after 4 weeks of daily treatment
State-Trait Anxiety Index (STAI)
Before and after 4 weeks of daily treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMay Care Inc.

Investigators

  • Principal Investigator: Hermina Strungaru, MD, University of Alberta

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 (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meibomian Gland Dysfunction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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