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

Alcon Research299 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

299

Conditions

Meibomian Gland Dysfunction Evaporative Dry Eye Disease

Interventions

Systane iLux® Dry Eye SystemDEVICE

Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.

LipiFlow® Thermal Pulsation SystemDEVICE

Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Alcon Investigator 9083

Long Beach, California, United States

Alcon Investigator 9081

Los Angeles, California, United States

Alcon Investigator 9084

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Month 12

Data from ClinicalTrials.gov

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