Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction

September 2, 2026 updated by: Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon
Dry eye syndrome is a common eye disease that affects 1 to 2 out of 10 persons around the planet. One common cause of this disease is the meibomian gland dysfunction. Meibomian glands are very small glands located at the rim of the eyelids that produce an oily substance that prevents the evaporation of tears. When these glands are compromised, the tear film evaporates quickly and the eyes dry up. This disease presents as eye irritation, foreign body sensation, inflammation, etc. The treatment of choice for MGD is eyelid massage and warm compresses 2 times a day. However, these treatments not always work perfectly, and as a result, patients find it hard to follow doctor's orders. Another kind of treatment is thermal therapy. There are several devices that are designed to apply heat on the eyelids, such as Lipiflow, MiBo Thermoflo, and Blephasteam. In this study, we want to find out whether thermal therapy with MiBo Thermoflo works better than warm compresses and eyelid massage use in the treatment of dry eye caused by MGD. To do this, we will select several patients and will assign them randomly to either the group with thermal therapy with MiBo Thermoflo or to the group with warm compresses and eyelid massage. The Mibo group will receive 3 sessions of thermal therapy at 2 weeks interval and the control group warm compresses and eyelid massage 2 times per day. All subjects will have a follow up of 24 weeks and we will compare results for both groups at the end of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dry eye syndrome is considered one of the most important ophthalmologic diseases, affecting 10 to 20% of the general population. Of these, 3.7% to 70% of cases are due to meibomian gland dysfunction (MGD). MGD is a chronic diffuse disease characterized by terminal duct obstruction and/or qualitative/quantitative changes in gland secretion. This causes a disruption in the tear film, ocular irritation symptom, inflammation, and ocular surface symptoms. The gold standard for the treatment of meibomian dysfunction is the use of warm compresses and eyelid massage 2 times a day. These have variable results and consequently patient's adherence to treatment is low. An alternative treatment is the use of thermal therapy devices such as Lipiflow, MiBo Thermoflo, and Blephasteam. The objective of this study is to determine if the thermal device MiBo Thermoflo is more effective than warm compresses and eyelid massage in the treatment of dry eye secondary to MGD. Participants will be randomly assigned to one of two groups: the Mibo group will receive 3 sessions of thermal therapy at 2 weeks interval and the control group warm compresses and eyelid massage 2 times per day. All subjects will have follow up of 24 weeks and we will compare results for both groups at the end of the study. During the protocol patients in both groups will continue with their standard treatment for dry eye as needed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with:

    • Dry eye syndrome with meibomian gland dysfunction alone or in combination of other type of dry eye.
    • Patients who were previously treated with eyelid massages and warm compresses without any improvement.

Exclusion Criteria:

  • Pregnant women.
  • History of ocular surgery within three months prior to inclusion.
  • History of trauma, infection or inflammation within three months prior to inclusion.
  • Contact lens use in the last week before inclusion.
  • Patients with active ocular allergic disease.
  • Patient with microbial keratitis.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mibo Thermoflo (thermal device)
Same at-home TheraPearl® regimen plus eyelid massage, and received three additional in-office MiBo Thermoflo® sessions at baseline and weeks 2 and 4. Each eye was treated at 42°C for 11 minutes. Previously prescribed dry eye disease treatments were maintained unchanged throughout follow-up.
Device: Mibo Thermoflo
Thermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.
Active Comparator: Warm compresses and eyelid massage
TheraPearl® gel-bead eye mask over closed eyelids for 11 minutes twice daily, followed by eyelid massage. Previously prescribed dry eye disease treatments were maintained unchanged throughout follow-up.
Other: Warm compresses and eyelid massage
Warm compresses plus eyelid massage 2 times per day 11 minutes per eye.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Meibomian gland expressibility
Time Frame: Basal to 24 weeks
Changes in meibomian gland structure will be evaluated by meibomian gland expressibility.
Basal to 24 weeks
Meibum quality
Time Frame: Basal to 24 weeks
Changes in meibomian gland structure will be evaluated with the meibum quality in slit lamp graded as: clear, opaque, granular and toothpaste for meibum worst secretion.
Basal to 24 weeks
Corneal and conjunctival staining with fluorescein dye
Time Frame: Basal to 24 weeks
Ocular surface damage will be graded with corneal and conjunctival staining with fluorescein dye.
Basal to 24 weeks
Corneal and conjunctival staining with lissamine green dye
Time Frame: Basal to 24 weeks
Ocular surface damage will be graded with corneal and conjunctival staining with lissamine green dye.
Basal to 24 weeks
Tear Break-up Time (TBUT)
Time Frame: Basal to 24 weeks
Tear stability will be measured with Tear Break-up Time (TBUT). A result >10 seconds will be considered normal, a result <10 seconds will be considered pathological.
Basal to 24 weeks
Schirmer test with and without anesthesia
Time Frame: Basal to 24 weeks
Tear production will be measured by Schirmer test with and without anesthesia. A Schirmer test >10 mm will be considered normal, a result >5 mm pathological. The Schirmer test with anesthesia >15 mm is consider normal.
Basal to 24 weeks
Symptom Assessment in Dry Eye questionnaire (SANDE)
Time Frame: Basal to 24 weeks
Ocular surface symptoms will be assessed by the Symptom Assessment in Dry Eye (SANDE) questionnaire. The SANDE questionnaire has two questions presented in a visual scale. The two questions assess the frequency and severity of dry eye symptoms.
Basal to 24 weeks
Ocular Surface Disease Index (OSDI)
Time Frame: Basal to 24 weeks
Ocular surface symptoms will be assessed by the Ocular Surface Disease Index (OSDI). The OSDI questionnaire consists of 12 questions that assess dry eye symptoms and their effects on vision related function. The questionnaire is divided in 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients are asked to rate their responses on a 0 to 4 scale where 0 represents "none of the time", 1 "some of the time", 2 "half of the time", 3 "most of the time", and 4 "all of the time". The total score is calculated using the following formula: ([sum of scores for all questions answered x 100] / [total number of questions answered x 4]). Lower scores represent a better outcome.
Basal to 24 weeks
Dry Eye Questionnaire 5 (DEQ-5)
Time Frame: Basal to 24 weeks
Ocular surface symptoms will be assessed by the Dry Eye Questionnaire 5 (DEQ-5). The Dry Eye Questionnaire 5 asses habitual dry eye symptoms (discomfort, dryness and wetty eyes) and severity level.
Basal to 24 weeks
Tear osmolarity
Time Frame: Basal to 24 weeks
Patients with dry eye have increased levels of tear osmolarity wich is one of tear inflammation biomarkers. Tear osmolarity will be performed with Tear Lab Osmolarity System, a result of 308 mOsm/L or higher indicates dry eye disease.
Basal to 24 weeks
Change in tear of matrix metalloproteinase 9 (MMP-9)
Time Frame: Basal to 24 weeks
MMP-9 is an inflammatory biomarker wich is elevated in the tears of patients with dry eye and an early diagnostic evaluation, it is realized in consulting room with the InflammaDry test (Rapid Pathogen Screening Inc.). The presence of 1 line is a negative result and two lines means positive result.
Basal to 24 weeks
Non-Invasive Keratograph Break-up Time (NIKBUT)
Time Frame: Basal to 24 weeks
NIKBUT will be measured with Keratograph 5M. A JENVIS Dry Eye report will be generated to document findings.
Basal to 24 weeks
Tear meniscus height
Time Frame: Basal to 24 weeks
Tear meniscus height will be measured with Keratograph 5M. A JENVIS Dry Eye report will be generated to document findings.
Basal to 24 weeks
Conjuctival hyperemia
Time Frame: Basal to 24 weeks
Conjuctival hypermeia will be graded with JENVIS Scale performed by Keratograph 5M. A JENVIS Dry Eye report will be generated to document findings. Conjuctival hyperemia will be . graded as: none, mild moderate or severe.
Basal to 24 weeks
Lipid layer thickness
Time Frame: Basal to 24 weeks
Lipid layer thickness will be measured with Keratograph 5M. A JENVIS Dry Eye report will be generated to document findings.
Basal to 24 weeks
Adverse events
Time Frame: Basal to 24 weeks
Adverse events will be evaluated during the ophthalmic evaluation.
Basal to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short term changes with corneal and conjunctival staining with fluorescein dye
Time Frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface damage will be graded with corneal and conjunctival staining with fluorescein dye.
These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes with corneal and conjunctival staining with lissamine green dye
Time Frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface damage will be graded with corneal and conjunctival staining with lissamine green dye.
These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in tear stability
Time Frame: These parameterd will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in tear stability will be measured with Tear Break-up Time (TBUT). A result >10 seconds will be considered normal, a result <10 seconds will be considered pathological.
These parameterd will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in Symptom Assessment in Dry Eye questionnaire (SANDE)
Time Frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface symptoms will be assessed by the Symptom Assessment in Dry Eye (SANDE). The SANDE questionnaire has two questions presented in a visual scale. The two questions assess the frequency and severity of dry eye symptoms. A less rate prove changes in ocular surface symptoms and quality of life improvement.
These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in Ocular Surface Disease Index (OSDI)
Time Frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface symptoms will be assessed by the Ocular Surface Disease Index (OSDI). The OSDI questionnaire consists of 12 questions that assess dry eye symptoms and their effects on vision related function. The questionnaire is divided in 3 subscales: ocular symptoms, vision-related function, and environmental triggers.. A less rate prove changes in ocular surface symptoms and quality of life improvement.
These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in Dry Eye Questionnaire 5 (DEQ-5)
Time Frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in ocular surface symptoms will be assessed by the Dry Eye Questionnaire 5 (DEQ-5). The Dry Eye Questionnaire 5 asses habitual dry eye symptoms (discomfort, dryness and wetty eyes) and severity level. A less rate prove changes in coular surface symptoms and quality of life improvement.
These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Eyelid skin temperature
Time Frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Eyelid skin temperature will be measured with the thermographic infrared scientific equipment FLIR SC4000 to verify if 42 celsius degree are obtain as maker recommends.
These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Corneal conjunctival temperature
Time Frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Corneal conjunctival temperature will be measured with the thermographic infrared scientific equipment FLIR SC4000 to verify if 42 celsius degree are obtain as maker recommends.
These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Bulbar conjunctival temperature
Time Frame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Bulbar conjunctival temperature will be measured with the thermographic infrrared scientific equipment FLIR SC4000 to verify if 42 celsius degree are obtain as maker recommends.
These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Tarsal conjunctival temperature
Time Frame: These parameters will be evaluated before sessions of thermal therapy at week 2 and week 4.
Tarsal conjunctival temperature will be measured with the thermographic infrared scientific equipment FLIR SC4000 to verify if 42 celsius degree are obtain as maker recommends.
These parameters will be evaluated before sessions of thermal therapy at week 2 and week 4.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Nuevo Leon

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitario Dr. Jose E. Gonzalez

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karim Mohamed-Noriega, M.D., Hospital Universitario Dr. Jose E. Gonzalez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OF18-00006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

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