- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04310969
Clinical Effect of MiboFlo in Dry Eye Patients
July 21, 2020 updated by: Beijing Tongren Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100010
- Beijing Tongren Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment group
Patients are treated every two weeks for a total of three times.
Forceful expression of the meibomian glands is followed after each therapy.
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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.
Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
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Sham Comparator: control group
Forceful expression of the meibomian glands only for patients.
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Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
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Active Comparator: active control group
LipiFlow® treatment is used as an active comparator.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
subjective symptom score
Time Frame: 2 weeks
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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.
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2 weeks
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Meibomian Glands Yielding Liquid Secretion (MGYLS)
Time Frame: 2 weeks
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The total number of MGYLS was counted for both upper and lower lid of each eye.
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2 weeks
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Meibomian Glands Secretion (MGS)
Time Frame: 2 weeks
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The total number of MGYLS was counted for both upper and lower lid of each eye.
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2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Corneal Fluorescein Staining(CFS)
Time Frame: 2 weeks
|
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
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2 weeks
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Tear Meniscus Height(TMH)
Time Frame: 2 weeks
|
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.
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2 weeks
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Non-invasive Keratograph Break-up Time(NIKBUT)
Time Frame: 2 weeks
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The NIKBUT was used to evaluate tear film stability and assessed by Oculus Keratograph 5M.
The average NIKBUT was recorded into the statistical result.
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2 weeks
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Meibography
Time Frame: 2 weeks
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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
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ying Jie, M.D, Beijing Tongren Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2020
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
March 14, 2020
First Submitted That Met QC Criteria
March 15, 2020
First Posted (Actual)
March 17, 2020
Study Record Updates
Last Update Posted (Actual)
July 23, 2020
Last Update Submitted That Met QC Criteria
July 21, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRECKY2019-099
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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