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OpenTrials
Completed

NCT Number: NCT04229888

Meibomian Gland Dysfunction Treatment

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

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Key information

Conditions

Meibomian Gland Dysfunction Dry Eye Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Optometry

Bloomington, Indiana, 47405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LipiFlow

Device

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

Light Based (Sham) Treatment

Device

A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2020
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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