Clinical trial NCT03767530: Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction
Official title: Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meibomian Gland Dysfunction
Keywords: Meibomian gland dysfunction
Mibo
MGD
Dry eye disease
Thermic devices
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Dr. Jose E. Gonzalez
First posted: 2018-12-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will be ophthalmologically evaluated before treatment and at weeks 8, 16 and 24. Subjects will be randomly assigned into 2 study groups. Mibo group will have 3 sessions (basal, week 2, week 4) of thermal therapy with Mibo Thermoflo in both eyes. The control group will use warm compresses and eyelid massage 2 times per day in both eyes. At the week 16 control group will also have 3 sessions of Mibo therapy at 2 weeks interval.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Meibomian gland expressibility
timeFrame: Basal to 24 weeks
measure: Meibum quality
timeFrame: Basal to 24 weeks
measure: Corneal and conjunctival staining with fluorescein dye
timeFrame: Basal to 24 weeks
measure: Corneal and conjunctival staining with lissamine green dye
timeFrame: Basal to 24 weeks
measure: Tear Break-up Time (TBUT)
timeFrame: Basal to 24 weeks
measure: Schirmer test with and without anesthesia
timeFrame: Basal to 24 weeks
measure: Symptom Assessment in Dry Eye questionnaire (SANDE)
timeFrame: Basal to 24 weeks
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Basal to 24 weeks
measure: Dry Eye Questionnaire 5 (DEQ-5)
timeFrame: Basal to 24 weeks
measure: Tear osmolarity
timeFrame: Basal to 24 weeks
measure: Change in tear of matrix metalloproteinase 9 (MMP-9)
timeFrame: Basal to 24 weeks
measure: Non-Invasive Keratograph Break-up Time (NIKBUT)
timeFrame: Basal to 24 weeks
measure: Tear meniscus height
timeFrame: Basal to 24 weeks
measure: Conjuctival hyperemia
timeFrame: Basal to 24 weeks
measure: Lipid layer thickness
timeFrame: Basal to 24 weeks
measure: Adverse events
timeFrame: Basal to 24 weeks
Secondary outcomes:
measure: Short term changes with corneal and conjunctival staining with fluorescein dye
timeFrame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Short term changes with corneal and conjunctival staining with lissamine green dye
timeFrame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Short term changes in tear stability
timeFrame: These parameterd will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Short term changes in Symptom Assessment in Dry Eye questionnaire (SANDE)
timeFrame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Short term changes in Ocular Surface Disease Index (OSDI)
timeFrame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Short term changes in Dry Eye Questionnaire 5 (DEQ-5)
timeFrame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Eyelid skin temperature
timeFrame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Corneal conjunctival temperature
timeFrame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Bulbar conjunctival temperature
timeFrame: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
measure: Tarsal conjunctival temperature
timeFrame: These parameters will be evaluated before sessions of thermal therapy at week 2 and week 4.
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo Leon
Study officials:
affiliation: Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez
name: Karim Mohamed-Noriega, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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