Back to resultsClinical Effect of MiboFlo in Dry Eye Patients
Primary Purpose
Dry Eye Syndromes, Meibomian Gland Dysfunction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MiBoFlo Thermoflo
forceful expression of the meibomian glands
LipiFlow
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye, meibomian gland dysfunction, therapy
Eligibility Criteria
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.
Sites / Locations
- Beijing Tongren Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
treatment group
control group
active control group
Arm Description
Patients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy.
Forceful expression of the meibomian glands only for patients.
LipiFlow® treatment is used as an active comparator.
Outcomes
Primary Outcome Measures
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.
Meibomian Glands Yielding Liquid Secretion (MGYLS)
The total number of MGYLS was counted for both upper and lower lid of each eye.
Meibomian Glands Secretion (MGS)
The total number of MGYLS was counted for both upper and lower lid of each eye.
Secondary Outcome Measures
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
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04310969
Brief Title
Clinical Effect of MiboFlo in Dry Eye Patients
Official Title
Clinical Effect of MiboFlo in Dry Eye Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
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
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Meibomian Gland Dysfunction
Keywords
dry eye, meibomian gland dysfunction, therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Patients are treated every two weeks for a total of three times. Forceful expression of the meibomian glands is followed after each therapy.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
Forceful expression of the meibomian glands only for patients.
Arm Title
active control group
Arm Type
Active Comparator
Arm Description
LipiFlow® treatment is used as an active comparator.
Intervention Type
Device
Intervention Name(s)
MiBoFlo Thermoflo
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
forceful expression of the meibomian glands
Intervention Description
Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
Intervention Type
Device
Intervention Name(s)
LipiFlow
Intervention Description
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.
Primary Outcome Measure Information:
Title
subjective symptom score
Description
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.
Time Frame
2 weeks
Title
Meibomian Glands Yielding Liquid Secretion (MGYLS)
Description
The total number of MGYLS was counted for both upper and lower lid of each eye.
Time Frame
2 weeks
Title
Meibomian Glands Secretion (MGS)
Description
The total number of MGYLS was counted for both upper and lower lid of each eye.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Corneal Fluorescein Staining(CFS)
Description
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
Time Frame
2 weeks
Title
Tear Meniscus Height(TMH)
Description
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.
Time Frame
2 weeks
Title
Non-invasive Keratograph Break-up Time(NIKBUT)
Description
The NIKBUT was used to evaluate tear film stability and assessed by Oculus Keratograph 5M. The average NIKBUT was recorded into the statistical result.
Time Frame
2 weeks
Title
Meibography
Description
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
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Jie, M.D
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Effect of MiboFlo in Dry Eye Patients
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