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OpenTrials
Completed

NCT Number: NCT03956225

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

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.

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Key information

Conditions

Meibomian Gland Dysfunction Dry Eye Syndromes Evaporative Dry Eye Disease Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigator 9083, Long Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systane iLux® Dry Eye System

Device

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 System

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 20, 2019
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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