NCT04310969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

April 3, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

March 14, 2020

Last Update Submit

July 21, 2020

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Keywords

dry eyemeibomian gland dysfunctiontherapy

Outcome Measures

Primary Outcomes (3)

  • 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.

    2 weeks

  • Meibomian Glands Yielding Liquid Secretion (MGYLS)

    The total number of MGYLS was counted for both upper and lower lid of each eye.

    2 weeks

  • Meibomian Glands Secretion (MGS)

    The total number of MGYLS was counted for both upper and lower lid of each eye.

    2 weeks

Secondary Outcomes (4)

  • Corneal Fluorescein Staining(CFS)

    2 weeks

  • Tear Meniscus Height(TMH)

    2 weeks

  • Non-invasive Keratograph Break-up Time(NIKBUT)

    2 weeks

  • Meibography

    2 weeks

Study Arms (3)

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.

Device: MiBoFlo ThermofloProcedure: forceful expression of the meibomian glands

control group

SHAM COMPARATOR

Forceful expression of the meibomian glands only for patients.

Procedure: forceful expression of the meibomian glands

active control group

ACTIVE COMPARATOR

LipiFlow® treatment is used as an active comparator.

Device: LipiFlow

Interventions

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.

treatment group
forceful expression of the meibomian glandsPROCEDURE

Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force

control grouptreatment group
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.

active control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Officials

  • Ying Jie, M.D

    Beijing Tongren Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 17, 2020

Study Start

April 3, 2020

Primary Completion

May 15, 2020

Study Completion

June 30, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

CN(1)