N/A N=236 Randomized Single-blind Treatment

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

Meibomian Gland Dysfunction · Evaporative Dry Eye Disease

Bottom Line

View on ClinicalTrials.gov: NCT03956225 ↗

Enrolled (actual)

236

Serious AEs

0.4%

Results posted

Oct 2021

Primary outcome: Primary: Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 — 17.4; 17.8 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Systane iLux® Dry Eye System (Device); LipiFlow® Thermal Pulsation System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12	17.4; 17.8	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03956225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.