Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction

Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction

The purpose of this study was to compare changes in meibomian gland dysfunction (MGD), tear break-up time (TBT) and evaporative dry eye (EDE) symptoms after treatment with either the iLux® 2020 System or the LipiFlow® Thermal Pulsation System.

At the Baseline visit (Day 0), subjects were assessed pre-treatment, during treatment, and post-treatment.

Inclusion Criteria:

• Age 18 years and older of any gender or race
• Written informed consent to participate in the study
• Willingness and ability to return for all study visits
• Positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit
• Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure
• Tear break-up time <10 seconds
• Agreement/ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (ocular lubricants are allowed if no changes are made during the study)

Exclusion Criteria:

• History of ocular or corneal surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
• Subjects with giant papillary conjunctivitis
• Subject with punctal plugs or who have had punctal cautery
• Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination
• Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months
• Subjects who are aphakic
• Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
• Active ocular infection
• Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
• Ocular surface abnormality that may compromise corneal integrity
• Lid surface abnormalities that affect lid function in either eye
• Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
• Systemic disease conditions that cause dry eye
• Unwillingness to abstain from systemic medications known to cause dryness for the study duration
• Women who are pregnant, nursing, or not utilizing adequate birth control measures
• Individuals who have either changed the dosing of systemic medications or non-dry eye/MGD ophthalmic medications within the past 30 days prior to screening
• Individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study
• Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution 5% (Xiidra) within 3 months, or any other dry eye or MGD medications within 2 weeks of screening (ocular lubricants are allowed if no changes are made during the study)
• Individuals wearing contact lenses at any time during the prior three months or during the study period
• Eyelid tattoos, including permanent eyeliner makeup
• Individuals that were treated with LipiFlow in either eye in the last 24 months
• Individuals using another ophthalmic investigational device or agent within 30 days of study participation
• Individuals who are unable to complete the required patient questionnaires in English