Back to resultsInvestigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction, Dry Eye Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermal therapy device
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Dry Eye, Thermal Therapy, Meibomian Gland Dysfunction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thermal Therapy
Arm Description
Heat application using at home thermal therapy device
Outcomes
Primary Outcome Measures
Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
Ocular surface analysis of tear film evaporation
Secondary Outcome Measures
Change in Ocular Surface Disease Index (OSDI) Score
Standardized symptom questionnaire
Meibum Expressibility
Grade of Meibum oil expressibility from Meibomian Gland
Sleep Quality
Pittsburg Sleep Quality Index (PSQI)
State Trait and Anxiety
State-Trait Anxiety Index (STAI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03291704
Brief Title
Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction
Official Title
PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UMay Care Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Dry Eye Disease
Keywords
Dry Eye, Thermal Therapy, Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thermal Therapy
Arm Type
Experimental
Arm Description
Heat application using at home thermal therapy device
Intervention Type
Device
Intervention Name(s)
Thermal therapy device
Other Intervention Name(s)
umayREST
Intervention Description
Thermal therapy of blocked Meibomian glands
Primary Outcome Measure Information:
Title
Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
Description
Ocular surface analysis of tear film evaporation
Time Frame
Before and after 4 weeks of daily treatment
Secondary Outcome Measure Information:
Title
Change in Ocular Surface Disease Index (OSDI) Score
Description
Standardized symptom questionnaire
Time Frame
Before and after 4 weeks of daily treatment
Title
Meibum Expressibility
Description
Grade of Meibum oil expressibility from Meibomian Gland
Time Frame
Before and after 4 weeks of daily treatment
Title
Sleep Quality
Description
Pittsburg Sleep Quality Index (PSQI)
Time Frame
Before and after 4 weeks of daily treatment
Title
State Trait and Anxiety
Description
State-Trait Anxiety Index (STAI)
Time Frame
Before and after 4 weeks of daily treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharmin Habib, OD
Phone
5875017422
Email
sharmin@umay.care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hermina Strungaru, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction
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