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

September 13, 2021 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

299

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90815
        • Alcon Investigator 9083
      • Los Angeles, California, United States, 90013
        • Alcon Investigator 9081
      • San Diego, California, United States, 92122
        • Alcon Investigator 9084
    • Florida
      • Panama City, Florida, United States, 32405
        • Alcon Investigator 5127
    • Illinois
      • Highland Park, Illinois, United States, 60035
        • Alcon Investigator 4782
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Alcon Investigator 6567
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Alcon Investigator 5582
    • Minnesota
      • Medina, Minnesota, United States, 55340
        • Alcon Investigator 6402
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Alcon Investigator 1455
    • New York
      • Poughkeepsie, New York, United States, 12603
        • Alcon Investigator 3828
    • Ohio
      • Granville, Ohio, United States, 43023
        • Alcon Investigator 8046
      • Powell, Ohio, United States, 43065
        • Alcon Investigator 6313
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 17201
        • Alcon Investigator 9082
    • Texas
      • Wichita Falls, Texas, United States, 76308
        • Alcon Investigator 8028
    • Washington
      • Kirkland, Washington, United States, 98034
        • Alcon Investigator 5163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
Time Frame: 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.
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, Vision Care, Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2019

Primary Completion (Actual)

October 24, 2020

Study Completion (Actual)

October 24, 2020

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEG723-P001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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