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

NCT03767530 | Recruiting

• 1 other identifier: OF18-00006
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction

Keywords

Meibomian gland dysfunction; Mibo; MGD; Dry eye disease; Thermic devices

Outcome Measures

Primary Outcomes (16)

• Meibomian gland expressibility

  Changes in meibomian gland structure will be evaluated by meibomian gland expressibility.

  Basal to 24 weeks

• Meibum quality

  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

  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

  Ocular surface damage will be graded with corneal and conjunctival staining with lissamine green dye.

  Basal to 24 weeks

• Tear Break-up Time (TBUT)

  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

  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)

  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)

  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)

  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

  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)

  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)

  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

  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

  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

  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

  Adverse events will be evaluated during the ophthalmic evaluation.

  Basal to 24 weeks

Secondary Outcomes (10)

• Short term changes 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

  These parameters will be evaluated before sessions of termal therapy at week 2 and week 4

• Short term changes in tear stability

  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)

  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)

  These parameters will be evaluated before sessions of termal therapy at week 2 and week 4

Study Arms (2)

Mibo Thermoflo (thermal device)

EXPERIMENTAL

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

Warm compresses and eyelid massage

ACTIVE COMPARATOR

2 times per day, 11 minutes per eye.

Other: Warm compresses and eyelid massage

Interventions

Mibo Thermoflo DEVICE

Thermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.

Mibo Thermoflo (thermal device)

Warm compresses and eyelid massage OTHER

Warm compresses plus eyelid massage 2 times per day 11 minutes per eye.

Warm compresses and eyelid massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women.
• Patients with active ocular allergic disease.
• Patient with microbial keratitis.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• Hospital Universitario Dr. Jose E. Gonzalez: collaborator

Study Sites (1)

Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (17)

• Arita R, Morishige N, Shirakawa R, Sato Y, Amano S. Effects of Eyelid Warming Devices on Tear Film Parameters in Normal Subjects and Patients with Meibomian Gland Dysfunction. Ocul Surf. 2015 Oct;13(4):321-30. doi: 10.1016/j.jtos.2015.04.005. Epub 2015 May 30.

  PMID: 26031204 BACKGROUND

• Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

  PMID: 28736335 BACKGROUND

• 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.

  BACKGROUND

• Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.

  PMID: 21450919 BACKGROUND

• Hom M, De Land P. Prevalence and severity of symptomatic dry eyes in Hispanics. Optom Vis Sci. 2005 Mar;82(3):206-8. doi: 10.1097/01.opx.0000156310.45736.fa.

  PMID: 15767875 BACKGROUND

• Johnson ME, Murphy PJ. Changes in the tear film and ocular surface from dry eye syndrome. Prog Retin Eye Res. 2004 Jul;23(4):449-74. doi: 10.1016/j.preteyeres.2004.04.003.

  PMID: 15219877 BACKGROUND

• Jones L, Downie LE, Korb D, Benitez-Del-Castillo JM, Dana R, Deng SX, Dong PN, Geerling G, Hida RY, Liu Y, Seo KY, Tauber J, Wakamatsu TH, Xu J, Wolffsohn JS, Craig JP. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017 Jul;15(3):575-628. doi: 10.1016/j.jtos.2017.05.006. Epub 2017 Jul 20.

  PMID: 28736343 BACKGROUND

• Kenrick CJ, Alloo SS. The Limitation of Applying Heat to the External Lid Surface: A Case of Recalcitrant Meibomian Gland Dysfunction. Case Rep Ophthalmol. 2017 Jan 16;8(1):7-12. doi: 10.1159/000455087. eCollection 2017 Jan-Apr.

  PMID: 28203190 BACKGROUND

• Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.

  PMID: 22378109 BACKGROUND

• Mori A, Shimazaki J, Shimmura S, Fujishima H, Oguchi Y, Tsubota K. Disposable eyelid-warming device for the treatment of meibomian gland dysfunction. Jpn J Ophthalmol. 2003 Nov-Dec;47(6):578-86. doi: 10.1016/s0021-5155(03)00142-4.

  PMID: 14636848 BACKGROUND

• Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.

  PMID: 21450914 BACKGROUND

• Pult H, Riede-Pult BH, Purslow C. A comparison of an eyelid-warming device to traditional compress therapy. Optom Vis Sci. 2012 Jul;89(7):E1035-41. doi: 10.1097/OPX.0b013e31825c3479.

  PMID: 22729167 BACKGROUND

• Qiao J, Yan X. Emerging treatment options for meibomian gland dysfunction. Clin Ophthalmol. 2013;7:1797-803. doi: 10.2147/OPTH.S33182. Epub 2013 Sep 9.

  PMID: 24043929 BACKGROUND

• Schaumberg DA, Nichols JJ, Papas EB, Tong L, Uchino M, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on the epidemiology of, and associated risk factors for, MGD. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1994-2005. doi: 10.1167/iovs.10-6997e. Print 2011 Mar. No abstract available.

  PMID: 21450917 BACKGROUND

• Wang MT, Jaitley Z, Lord SM, Craig JP. Comparison of Self-applied Heat Therapy for Meibomian Gland Dysfunction. Optom Vis Sci. 2015 Sep;92(9):e321-6. doi: 10.1097/OPX.0000000000000601.

  PMID: 25955642 BACKGROUND

• Wang X, Lu X, Yang J, Wei R, Yang L, Zhao S, Wang X. Evaluation of Dry Eye and Meibomian Gland Dysfunction in Teenagers with Myopia through Noninvasive Keratograph. J Ophthalmol. 2016;2016:6761206. doi: 10.1155/2016/6761206. Epub 2016 Jan 6.

  PMID: 26881059 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Karim Mohamed-Noriega, M.D.

  Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim Mohamed-Noriega, M.D.

CONTACT

+52 8183469259; karim.mohamednrg@uanl.edu.mx,drkmohamed1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not blinded study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: December 6, 2018
• Study Start: September 1, 2019
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)