Meibomian Gland DysfunctionNCT03291704
Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction
A study testing Thermal therapy device in people with Meibomian Gland Dysfunction and Dry Eye Disease, run by UMay Care Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye Disease
- What is being tested?
- Thermal therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of MGD
- Minimum age 18 years
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Conditions
- Meibomian Gland Dysfunction, Dry Eye Disease
- Being tested
- Thermal therapy device
- Keywords
- Dry Eye, Thermal Therapy, Meibomian Gland Dysfunction
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal therapy deviceDevice
Also called umayREST
Thermal therapy of blocked Meibomian glands
| Study group | Role | What they receive |
|---|---|---|
| Thermal Therapy | Experimental | Heat application using at home thermal therapy device Receives: Device: Thermal therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
Ocular surface analysis of tear film evaporation
Measured: Before and after 4 weeks of daily treatment
Secondary outcomes (4)
Change in Ocular Surface Disease Index (OSDI) Score
Standardized symptom questionnaire
Measured: Before and after 4 weeks of daily treatment
Meibum Expressibility
Grade of Meibum oil expressibility from Meibomian Gland
Measured: Before and after 4 weeks of daily treatment
Sleep Quality
Pittsburg Sleep Quality Index (PSQI)
Measured: Before and after 4 weeks of daily treatment
State Trait and Anxiety
State-Trait Anxiety Index (STAI)
Measured: Before and after 4 weeks of daily treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study startMar 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMay Care Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hermina Strungaru, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291704
- Sponsor's protocol ID
- Meibomian Gland Dysfunction
- Status last verified
- Mar 2018
- First submitted
- 12 Sep 2017
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT03291704
- Acronym / sponsor ID
- Meibomian Gland Dysfunction
- Conditions
- Meibomian Gland Dysfunction, Dry Eye Disease
- Keywords
- Dry Eye, Thermal Therapy, Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UMay Care Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermal Therapy | Experimental | Device: Thermal therapy deviceHeat application using at home thermal therapy device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of MGD
- Minimum age 18 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal therapy deviceAlso: umayRESTThermal therapy of blocked Meibomian glands | Device | Thermal Therapy |
Primary outcome
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
4 secondary outcomes
Change in Ocular Surface Disease Index (OSDI) Score
Time frame: Before and after 4 weeks of daily treatment
Meibum Expressibility
Time frame: Before and after 4 weeks of daily treatment
Sleep Quality
Time frame: Before and after 4 weeks of daily treatment
State Trait and Anxiety
Time frame: Before and after 4 weeks of daily treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Meibomian Gland Dysfunction
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Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
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TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
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Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
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Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermina Strungaru, MD principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A study testing Thermal therapy device in people with Meibomian Gland Dysfunction and Dry Eye Disease, run by UMay Care Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharmin Habib, OD (5875017422, sharmin@umay.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds (time frame: Before and after 4 weeks of daily treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.