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Meibomian Gland Dysfunction Treatment

Primary Purpose

Meibomian Gland Dysfunction, Dry Eye

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LipiFlow
Light Based (Sham) Treatment
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring dry eye, meibomian gland dysfunction, lipiflow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University School of Optometry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subject Treatment

Arm Description

All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.

Outcomes

Primary Outcome Measures

Dry Eye Questionnaire 5 (DEQ-5) Score
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.

Secondary Outcome Measures

Meibomian Gland Score
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)
Tear Break-Up Time (TBUT)
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.

Full Information

First Posted
January 13, 2020
Last Updated
March 2, 2022
Sponsor
Indiana University
Collaborators
Indiana University School of Optometry
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1. Study Identification

Unique Protocol Identification Number
NCT04229888
Brief Title
Meibomian Gland Dysfunction Treatment
Official Title
Meibomian Gland Dysfunction Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
March 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Indiana University School of Optometry

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 purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Dry Eye
Keywords
dry eye, meibomian gland dysfunction, lipiflow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive first treatment and then second treatment. The eye receiving treatment will be randomly selected. The same eye will receive both treatments.
Masking
None (Open Label)
Masking Description
Outcomes assessor blinded to visit schedule. Participants masked to invalidity of sham treatment.
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subject Treatment
Arm Type
Experimental
Arm Description
All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
Intervention Type
Device
Intervention Name(s)
LipiFlow
Other Intervention Name(s)
Johnson & Johnson
Intervention Description
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Intervention Type
Device
Intervention Name(s)
Light Based (Sham) Treatment
Intervention Description
A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.
Primary Outcome Measure Information:
Title
Dry Eye Questionnaire 5 (DEQ-5) Score
Description
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Meibomian Gland Score
Description
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)
Time Frame
2 weeks
Title
Tear Break-Up Time (TBUT)
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Indiana University School of Optometry
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States

12. IPD Sharing Statement

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Meibomian Gland Dysfunction Treatment

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