ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03767530
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
Hospital Universitario Dr. Jose E. Gonzalez
Information provided by (Responsible Party):
Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon

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.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Device: Mibo Thermoflo Other: Warm compresses and eyelid massage Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: Not blinded study.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Mibo Thermoflo (thermal device)
3 sessions at 2 weeks interval (basal, week 2, week 4)of 11 minutes per eye of thermal therapy with Mibo Thermoflo.
Device: Mibo Thermoflo
Thermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.

Active Comparator: Warm compresses and eyelid massage
2 times per day, 11 minutes per eye.
Other: Warm compresses and eyelid massage
Warm compresses plus eyelid massage 2 times per day 11 minutes per eye.




Primary Outcome Measures :
  1. Meibomian gland expressibility [ Time Frame: Basal to 24 weeks ]
    Changes in meibomian gland structure will be evaluated by meibomian gland expressibility.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Adverse events [ Time Frame: Basal to 24 weeks ]
    Adverse events will be evaluated during the ophthalmic evaluation.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767530


Contacts
Contact: Karim Mohamed-Noriega, M.D. +52 8183469259 karim.mohamednrg@uanl.edu.mx,drkmohamed1@gmail.com

Locations
Mexico
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Karim Mohamed-Noriega, M.D.    +52 81 83469259    karim.mohamednrg@uanl.edu.mx, drkmohamed1@gmail.com   
Principal Investigator: Karim Mohamed-Noriega, M.D.         
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: Karim Mohamed-Noriega, M.D. Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez

Publications:
Foulks, G. N., Lemp, M., Jester, J., Sutphin, J., Murube, J., & Novack, G. (2007). report of the international dry eye workshop (DEWS). Ocul Surf, 5(2), 65-204. Foulks, G. N., Lemp, M., Jester, J., Sutphin, J., Murube, J., & Novack, G. (2007). Report of the international dry eye workshop (DEWS). Ocul Surf, 5(2), 65-204.
Stetson G. & Kenrick Ch. (2018). A comparision of four warm compress devices. The Association of Research in Vision and Ophthalmology (ARVO). Honolulu Hawaii. 953-B0131.

Responsible Party: Karim Mohamed-Noriega, Professor, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03767530     History of Changes
Other Study ID Numbers: OF18-00006
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon:
Meibomian gland dysfunction
Mibo
MGD
Dry eye disease
Thermic devices