Meibomian Gland DysfunctionNCT03767530
Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction
A study testing Mibo Thermoflo and Warm compresses and eyelid massage in people with Meibomian Gland Dysfunction, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Mibo Thermoflo and Warm compresses and eyelid massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2019to 20 Sep 2025
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460
About this study
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.
Read the 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.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Mibo Thermoflo, Warm compresses and eyelid massage
- Keywords
- Meibomian gland dysfunction, Mibo, MGD, Dry eye disease, Thermic devices
- 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.
Mibo ThermofloDevice
Thermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.
Warm compresses and eyelid massageOther
Warm compresses plus eyelid massage 2 times per day 11 minutes per eye.
| Study group | Role | What they receive |
|---|---|---|
| Mibo Thermoflo (thermal device) | Experimental | 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. Receives: Device: Mibo Thermoflo |
| Warm compresses and eyelid massage | Active comparator | 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. Receives: Other: Warm compresses and eyelid massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian gland expressibility
Changes in meibomian gland structure will be evaluated by meibomian gland expressibility.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Basal to 24 weeks
Adverse events
Adverse events will be evaluated during the ophthalmic evaluation.
Measured: Basal to 24 weeks
Secondary outcomes (10)
Short term changes with corneal and conjunctival staining with fluorescein dye
Short term changes in ocular surface damage will be graded with corneal and conjunctival staining with fluorescein dye.
Measured: 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
Short term changes in ocular surface damage will be graded with corneal and conjunctival staining with lissamine green dye.
Measured: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Short term changes in tear stability
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Eyelid skin temperature
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.
Measured: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Corneal conjunctival temperature
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.
Measured: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Bulbar conjunctival temperature
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.
Measured: These parameters will be evaluated before sessions of termal therapy at week 2 and week 4
Tarsal conjunctival temperature
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.
Measured: These parameters will be evaluated before sessions of thermal therapy at week 2 and week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Sep 2019
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Responsible party
- Principal investigator, Karim Mohamed-Noriega, Universidad Autonoma de Nuevo Leon
- Investigators
- Karim Mohamed-Noriega, M.D., Principal investigator, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767530
- Sponsor's protocol ID
- OF18-00006
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2018
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26031204Craig 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.
PubMed 28736335Foulks, 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.
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.
PubMed 21450919Hom 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.
PubMed 15767875Johnson 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.
PubMed 15219877Jones 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.
PubMed 28736343Kenrick 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.
PubMed 28203190Lemp 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.
PubMed 22378109Mori 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.
PubMed 14636848Nelson 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.
PubMed 21450914Pult 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.
PubMed 22729167Qiao 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.
PubMed 24043929Schaumberg 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.
PubMed 21450917Wang 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.
PubMed 25955642
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT03767530
- Acronym / sponsor ID
- OF18-00006
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Meibomian gland dysfunction, Mibo, MGD, Dry eye disease, Thermic devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Collaborators
- Hospital Universitario Dr. Jose E. Gonzalez
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 6 Dec 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mibo Thermoflo (thermal device) | Experimental | Device: Mibo ThermofloSame 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. |
| Warm compresses and eyelid massage | Active comparator | Other: Warm compresses and eyelid massageTheraPearl® 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with:
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Mibo ThermofloThermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session. | Device | Mibo Thermoflo (thermal device) |
| Warm compresses and eyelid massageWarm compresses plus eyelid massage 2 times per day 11 minutes per eye. | Other | Warm compresses and eyelid massage |
Primary outcome
Meibomian gland expressibility
Time frame: Basal to 24 weeks
Changes in meibomian gland structure will be evaluated by meibomian gland expressibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Adverse events
Time frame: Basal to 24 weeks
Adverse events will be evaluated during the ophthalmic evaluation.
10 secondary outcomes
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 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 tear stability
Time frame: 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 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 Dry Eye Questionnaire 5 (DEQ-5)
Time frame: 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
Corneal conjunctival temperature
Time frame: 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
Tarsal conjunctival temperature
Time frame: These parameters will be evaluated before sessions of thermal therapy at week 2 and week 4.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 26031204Arita 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.
- Background: PubMed 28736335Craig 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.
- BackgroundFoulks, 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: PubMed 21450919Geerling 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.
- Background: PubMed 15767875Hom 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.
- Background: PubMed 15219877Johnson 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.
- Background: PubMed 28736343Jones 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.
- Background: PubMed 28203190Kenrick 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.
- Background: PubMed 22378109Lemp 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.
- Background: PubMed 14636848Mori 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.
- Background: PubMed 21450914Nelson 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.
- Background: PubMed 22729167Pult 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.
- Individual participant dataSharing planned: No
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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.
Karim Mohamed-Noriega, M.D. principal investigator
Hospital Universitario Dr. Jose E. Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mibo Thermoflo and Warm compresses and eyelid massage in people with Meibomian Gland Dysfunction, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibomian gland expressibility (time frame: Basal to 24 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767530, which also lists 17 linked publications.
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 9 Sep 2026.