Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study

Study Overview
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Brief Summary
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The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.

Detailed Description
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Subjects will be expected to attend a total of 8 study visits, including Screening/Baseline, Treatment, and follow-up visits at Week 2 and Months 1, 3, 6, 9, and 12.

Official Title
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Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study

Conditions
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Meibomian Gland Dysfunction, Evaporative Dry Eye Disease

Intervention / Treatment
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* Device: Systane iLux® Dry Eye System
* Device: LipiFlow® Thermal Pulsation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand and sign an Informed Consent document; Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit; Agree not to wear contact lenses for the duration of the study; Other protocol-specified inclusion criteria may apply. Exclusion Criteria History of eye surgery, as specified in the protocol; Eye infection or inflammation, as specified in the protocol; Eyelid abnormalities; eyelid tattoos; Treated with LipiFlow or iLux in either eye in the last 12 months; Contact lens wear within the 1 month prior to Screening; Other protocol-specified exclusion criteria may apply.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iLux<br>Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated. | Device: Systane iLux® Dry Eye System<br>* Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.<br>|
| Active Comparator: LipiFlow<br>Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated. | Device: LipiFlow® Thermal Pulsation System<br>* Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 | Meibomian glands on the eyelids were assessed by the examiner using a Meibomian Gland Evaluator and a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring was follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function. | Baseline, Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, MGD