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

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.

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.

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.