NCT03291704

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Status
unknown

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

September 12, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

September 12, 2017

Last Update Submit

March 15, 2018

Conditions

Meibomian Gland DysfunctionDry Eye Disease

Keywords

Dry EyeThermal TherapyMeibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds

    Ocular surface analysis of tear film evaporation

    Before and after 4 weeks of daily treatment

Secondary Outcomes (4)

  • Change in Ocular Surface Disease Index (OSDI) Score

    Before and after 4 weeks of daily treatment

  • Meibum Expressibility

    Before and after 4 weeks of daily treatment

  • Sleep Quality

    Before and after 4 weeks of daily treatment

  • State Trait and Anxiety

    Before and after 4 weeks of daily treatment

Study Arms (1)

Thermal Therapy

EXPERIMENTAL

Heat application using at home thermal therapy device

Device: Thermal therapy device

Interventions

Thermal therapy deviceDEVICE

Thermal therapy of blocked Meibomian glands

Also known as: umayREST
Thermal Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of MGD
  • Minimum age 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meibomian Gland DysfunctionDry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesLacrimal Apparatus Diseases

Study Officials

  • Hermina Strungaru, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharmin Habib, OD

CONTACT

5875017422sharmin@umay.care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 25, 2017

Study Start

March 1, 2018

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03