Meibomian Gland Dysfunction Treatment

March 2, 2022 updated by: Anna Tichenor, Indiana University
The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Indiana University School of Optometry

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:

  • evidence of meibomian gland obstruction in both eyes
  • dry eye symptoms per DEQ-5

Exclusion Criteria:

  • active ocular infection
  • previous LipiFlow treatment
  • beginning new oral or other systemic medications within prior 3 months
  • beginning new or changing dosages of ocular medications within prior 3 months
  • previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months
  • habitual contact lens wear in prior 3 months
  • women who are pregnant or nursing

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subject Treatment
All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
Device: LipiFlow
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Other Names:
  • Johnson & Johnson
Device: Light Based (Sham) Treatment
A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry Eye Questionnaire 5 (DEQ-5) Score
Time Frame: 2 weeks
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meibomian Gland Score
Time Frame: 2 weeks
Meibomian glands evaluated on the lower eyelid using meibomian gland evaluator. 5 glands in 3 regions (nasal, central, temporal) evaluated and scored from 0 to 4 for a max score of 60 in each eye. (MGS scale 0 = clear, 1 = cloudy, 2 = granular, 3 = pastelike, 4 = obstruction)
2 weeks
Tear Break-Up Time (TBUT)
Time Frame: 2 weeks
Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBUT. A positive change value represents a lengthening in the tear break-up time and greater comfort.
2 weeks

Collaborators and Investigators

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

Sponsor

Indiana University

Collaborators

Indiana University School of Optometry

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)

February 26, 2020

Primary Completion (Actual)

March 25, 2021

Study Completion (Actual)

March 25, 2021

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1908329543

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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