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

Not Applicable

Completed

• Conditions: Evaporative Dry Eye Disease; Meibomian Gland Dysfunction
• Interventions: Device: Systane iLux® Dry Eye System; Device: LipiFlow® Thermal Pulsation System

• Registration Number: NCT03956225
• Lead Sponsor: Alcon Research

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Start: 2019-06-25
• Primary Completion: 2020-10-24
• Study Completion: 2020-10-24
• Status Verified: 2021-09
• Results First Submitted: 2021-09-13
• Results First Submitted QC: 2021-09-13
• Last Update Submitted: 2021-09-13
• Results First Posted: 2021-10-08
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iLux	Systane iLux® Dry Eye System	Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated.
LipiFlow	LipiFlow® Thermal Pulsation System	Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12	Baseline, 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.

Trial Locations

Locations (15)

Alcon Investigator 9083; 🇺🇸 Long Beach, California, United States

Alcon Investigator 5127; 🇺🇸 Panama City, Florida, United States

Alcon Investigator 4782; 🇺🇸 Highland Park, Illinois, United States

Alcon Investigator 6567; 🇺🇸 Pittsburg, Kansas, United States

Alcon Investigator 6402; 🇺🇸 Medina, Minnesota, United States

Alcon Investigator 3828; 🇺🇸 Poughkeepsie, New York, United States

Alcon Investigator 6313; 🇺🇸 Powell, Ohio, United States

Alcon Investigator 9082; 🇺🇸 Chambersburg, Pennsylvania, United States

Alcon Investigator 8028; 🇺🇸 Wichita Falls, Texas, United States

Alcon Investigator 5163; 🇺🇸 Kirkland, Washington, United States

Alcon Investigator 9081; 🇺🇸 Los Angeles, California, United States

Alcon Investigator 5582; 🇺🇸 Louisville, Kentucky, United States

Alcon Investigator 1455; 🇺🇸 Kansas City, Missouri, United States

Alcon Investigator 9084; 🇺🇸 San Diego, California, United States

Alcon Investigator 8046; 🇺🇸 Granville, Ohio, United States