Dry Eye SyndromesNCT04310969
Clinical Effect of MiboFlo in Dry Eye Patients
A study testing MiBoFlo Thermoflo, forceful expression of the meibomian glands and LipiFlow in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The aim of this prospective study is to compare the changes between the patients receiving traditional treatment and the patients with MiBoFlo, evaluating the effectiveness of MiBoFlo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- MiBoFlo Thermoflo, forceful expression of the meibomian glands and LipiFlow
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2020to 30 Jun 2020
- 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
- 18 years of age of older;
- Meet the diagnostic criteria for dry eye developed by DEWS II: OSDI score≥15 points, TBUT≤10 minutes;
- Meet the signs of meibomian gland dysfunction
Who cannot join
- Had skin allergies or inflammation;
- Had active ocular infection or inflammation;
- Had history of ocular surgery, eyelid surgery or neurological paralysis within 6 months;
- Had history of systemic disease affecting ocular surface function, such as Stevens-Johnson syndrome, Sjögren syndrome etc.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective study is to compare the changes between the patients receiving traditional treatment and the patients with MiBoFlo, evaluating the effectiveness of MiBoFlo.
Read the detailed description
The MiBoFlo Thermoflo uses a proprietary thermoelectric heat pump to help meibum maximize liquefaction, improving the preservation and function of the tear film's evaporative component. It supplies continuous controlled heat to the outer skin of the eyelids, absorbing deep into the tissue and breaks down the hardened oils in the meibomian glands. We are trying to find a effective, safe and economical therapy for dry eye patients.
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- MiBoFlo Thermoflo, forceful expression of the meibomian glands, LipiFlow
- Keywords
- dry eye, meibomian gland dysfunction, therapy
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiBoFlo ThermofloDevice
Each treatment for each eye takes 10 minutes and is treated every two weeks for a total of three times. The device was preheated to 42.2℃ and the eyelid was cleaned and smeared with a small amount of ultrasound gel in order to reduce friction between the device and eyelid skin. Then massage the outer skin of the upper and lower eyelids for a period of 10 minutes. The patient's eyes keep closed during therapy.
forceful expression of the meibomian glandsProcedure or surgery
Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
LipiFlowDevice
LipiFlow treatment applies heat to the palpebral surface of eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces, thereby expressing the meibomian glands during heating.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Patients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy. Receives: Device: MiBoFlo Thermoflo; Procedure: forceful expression of the meibomian glands |
| control group | Sham comparator | Forceful expression of the meibomian glands only for patients. Receives: Procedure: forceful expression of the meibomian glands |
| active control group | Active comparator | LipiFlow® treatment is used as an active comparator. Receives: Device: LipiFlow |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective symptom score
Ocular Surface Disease Index (OSDI©) questionnaire was chosen to assess subjective symptoms of dry eye, which can demonstrate sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
Measured: 2 weeks
Meibomian Glands Yielding Liquid Secretion (MGYLS)
The total number of MGYLS was counted for both upper and lower lid of each eye.
Measured: 2 weeks
Meibomian Glands Secretion (MGS)
The total number of MGYLS was counted for both upper and lower lid of each eye.
Measured: 2 weeks
Secondary outcomes (4)
Corneal Fluorescein Staining(CFS)
Fluorescein was applied in the lower conjunctival sac of each eye with a fluorescein sodium ophthalmic strip (Jingming New Technological Development Co., Ltd, Tianjin, China), and corneal erosion assessed by CFS was scored using the following grading system: grade 0 indicated no corneal erosion, grade 1 indicated 1-5 punctate epithelial erosions seen inferiorly, grade 2 indicated 6-30 punctate epithelial erosions, grade 3 indicated more than 30 punctate epithelial erosions
Measured: 2 weeks
Tear Meniscus Height(TMH)
The lower eyelid tear meniscus was photographed under a white light source by Oculus Keratograph 5M, and TMH was measured with the built-in ruler in order to estimate tear secretion.
Measured: 2 weeks
Non-invasive Keratograph Break-up Time(NIKBUT)
The NIKBUT was used to evaluate tear film stability and assessed by Oculus Keratograph 5M. The average NIKBUT was recorded into the statistical result.
Measured: 2 weeks
Meibography
Meibography was performed using Meibo-Scan attached to the Oculus Keratograph 5M. Structural changes of meibomian were observed with infrared light source. Partial or complete loss of the meibomian glands was scored using the following grading system: grade 0 indicated no loss of meibomian glands, grade 1 indicated lost area less than one third of the total area of meibomian glands, grade 2 indicated lost area between one third and two thirds of total area, grade 3 indicated lost area more than two thirds of the total area
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start3 Apr 2020
- Primary completion15 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Jie, M.D, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310969
- Sponsor's protocol ID
- TRECKY2019-099
- Status last verified
- Jul 2020
- First submitted
- 14 Mar 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of MiboFlo in Dry Eye Patients
- ClinicalTrials.gov ID
- NCT04310969
- Acronym / sponsor ID
- TRECKY2019-099
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Keywords
- dry eye, meibomian gland dysfunction, therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Mar 2020 (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.
The aim of this prospective study is to compare the changes between the patients receiving traditional treatment and the patients with MiBoFlo, evaluating the effectiveness of MiBoFlo.
Detailed description
The MiBoFlo Thermoflo uses a proprietary thermoelectric heat pump to help meibum maximize liquefaction, improving the preservation and function of the tear film's evaporative component. It supplies continuous controlled heat to the outer skin of the eyelids, absorbing deep into the tissue and breaks down the hardened oils in the meibomian glands. We are trying to find a effective, safe and economical therapy for dry eye patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: MiBoFlo Thermoflo, Procedure: forceful expression of the meibomian glandsPatients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy. |
| control group | Sham comparator | Procedure: forceful expression of the meibomian glandsForceful expression of the meibomian glands only for patients. |
| active control group | Active comparator | Device: LipiFlowLipiFlow® treatment is used as an active comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age of older;
- Meet the diagnostic criteria for dry eye developed by DEWS II: OSDI score≥15 points, TBUT≤10 minutes;
- Meet the signs of meibomian gland dysfunction
Key exclusion criteria (4 listed)
- Had skin allergies or inflammation;
- Had active ocular infection or inflammation;
- Had history of ocular surgery, eyelid surgery or neurological paralysis within 6 months;
- Had history of systemic disease affecting ocular surface function, such as Stevens-Johnson syndrome, Sjögren syndrome etc.
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 |
|---|---|---|
| MiBoFlo ThermofloEach treatment for each eye takes 10 minutes and is treated every two weeks for a total of three times. The device was preheated to 42.2℃ and the eyelid was cleaned and smeared with a small amount of ultrasound gel in order to reduce friction between the device and eyelid skin. Then massage the outer skin of the upper and lower eyelids for a period of 10 minutes. The patient's eyes keep closed during therapy. | Device | treatment group |
| forceful expression of the meibomian glandsUtilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force | Procedure or surgery | control group, treatment group |
| LipiFlowLipiFlow treatment applies heat to the palpebral surface of eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces, thereby expressing the meibomian glands during heating. | Device | active control group |
Primary outcome
subjective symptom score
Time frame: 2 weeks
Ocular Surface Disease Index (OSDI©) questionnaire was chosen to assess subjective symptoms of dry eye, which can demonstrate sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
Meibomian Glands Yielding Liquid Secretion (MGYLS)
Time frame: 2 weeks
The total number of MGYLS was counted for both upper and lower lid of each eye.
Meibomian Glands Secretion (MGS)
Time frame: 2 weeks
The total number of MGYLS was counted for both upper and lower lid of each eye.
4 secondary outcomes
Corneal Fluorescein Staining(CFS)
Time frame: 2 weeks
Tear Meniscus Height(TMH)
Time frame: 2 weeks
Non-invasive Keratograph Break-up Time(NIKBUT)
Time frame: 2 weeks
Meibography
Time frame: 2 weeks
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 23 Jul 2020.
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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.
Ying Jie, M.D study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiBoFlo Thermoflo, forceful expression of the meibomian glands and LipiFlow in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Beijing Tongren Hospital at 1 site in China.
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 4 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 23 Jul 2020. 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 China. 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. Some participants in this study may receive a placebo. 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?
subjective symptom score (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2020.