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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956225
• Other study ID #: DEG723-P001
• Status: Completed
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: October 24, 2020

Study information

• Verified date: September 2021
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: October 24, 2020
• Est. primary completion date: October 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Evaporative Dry Eye Disease
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Alcon Investigator 9082	Chambersburg	Pennsylvania
United States	Alcon Investigator 8046	Granville	Ohio
United States	Alcon Investigator 4782	Highland Park	Illinois
United States	Alcon Investigator 1455	Kansas City	Missouri
United States	Alcon Investigator 5163	Kirkland	Washington
United States	Alcon Investigator 9083	Long Beach	California
United States	Alcon Investigator 9081	Los Angeles	California
United States	Alcon Investigator 5582	Louisville	Kentucky
United States	Alcon Investigator 6402	Medina	Minnesota
United States	Alcon Investigator 5127	Panama City	Florida
United States	Alcon Investigator 6567	Pittsburg	Kansas
United States	Alcon Investigator 3828	Poughkeepsie	New York
United States	Alcon Investigator 6313	Powell	Ohio
United States	Alcon Investigator 9084	San Diego	California
United States	Alcon Investigator 8028	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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