Meibomian Gland Dysfunction Treatment

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

Official Title
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Meibomian Gland Dysfunction Treatment

Conditions
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Meibomian Gland Dysfunction, Dry Eye

Intervention / Treatment
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* Device: LipiFlow
* Device: Light Based (Sham) Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Eye Questionnaire 5 (DEQ-5) Score | 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 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, meibomian gland dysfunction, lipiflow