N/A
Completed N=236
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
Source: ClinicalTrials.gov NCT03956225 ↗
Enrolled (actual)
236
Serious AEs
0.4%
Results posted
Oct 2021
Primary outcomePrimary: Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 — 17.4; 17.8 score on a scale
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.
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 | — |
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.
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. Informational only — not medical advice.