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Status unknownNCT03291704Updated Mar 19, 2018

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

An interventional study of Thermal therapy device in Meibomian Gland Dysfunction and Dry Eye Disease, sponsored by UMay Care Inc.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-19.

Sponsored by UMay Care Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Meibomian Gland Dysfunction
  • Dry Eye Disease

Keywords

  • Dry Eye
  • Thermal Therapy
  • Meibomian Gland Dysfunction
03

In context

Meibomian Gland Dysfunction

172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.

Browse Meibomian Gland Dysfunction studies →

Lead sponsor

This is the only study on the registry with UMay Care Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of MGD
  • Minimum age 18 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Thermal Therapy

    Heat application using at home thermal therapy device

    Device: Thermal therapy device

Interventions

  • DeviceThermal therapy device

    Thermal therapy of blocked Meibomian glands

    Also known as: umayREST

06

What researchers measure

Primary outcomes

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

    Ocular surface analysis of tear film evaporation

    Time frame: Before and after 4 weeks of daily treatment

Secondary outcomes

  1. Change in Ocular Surface Disease Index (OSDI) Score

    Standardized symptom questionnaire

    Time frame: Before and after 4 weeks of daily treatment

  2. Meibum Expressibility

    Grade of Meibum oil expressibility from Meibomian Gland

    Time frame: Before and after 4 weeks of daily treatment

  3. Sleep Quality

    Pittsburg Sleep Quality Index (PSQI)

    Time frame: Before and after 4 weeks of daily treatment

  4. State Trait and Anxiety

    State-Trait Anxiety Index (STAI)

    Time frame: Before and after 4 weeks of daily treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2018; primary completion for Jun 2018, 3 months later.

Of 22 industry-sponsored interventional studies with no phase under Meibomian Gland Dysfunction, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 3 months is below that.

Counting every sponsor, half of 74 studies reached it within 11 months; a quarter within 5 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2017
First posted
Sep 25, 2017
StartEst.
Mar 2018
Primary completionEst.
Jun 2018
CompletionEst.
Jul 2018
Last update
Mar 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03291704
Lead sponsor
UMay Care Inc.
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Mar 2018 (estimated)
Primary completion
Jun 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Mar 19, 2018

Study contacts

Sharmin Habib, OD
Contact
sharmin@umay.care
5875017422
Hermina Strungaru, MD
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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