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

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

    • Beijing
      • Beijing, Beijing, China, 100010
        • Beijing Tongren Hospital

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.
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
Sham Comparator: control group
Forceful expression of the meibomian glands only for patients.
Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
Active Comparator: active control group
LipiFlow® treatment is used as an active comparator.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks
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.
2 weeks
Meibomian Glands Secretion (MGS)
Time Frame: 2 weeks
The total number of MGYLS was counted for both upper and lower lid of each eye.
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
2 weeks
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.
2 weeks
Non-invasive Keratograph Break-up Time(NIKBUT)
Time Frame: 2 weeks
The NIKBUT was used to evaluate tear film stability and assessed by Oculus Keratograph 5M. The average NIKBUT was recorded into the statistical result.
2 weeks
Meibography
Time Frame: 2 weeks
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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