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

Tear Film Innovations

Status

Completed

Conditions

Meibomian Gland Dysfunction

Treatments

Device: LipiFlow Pulsation System

Device: iLux 2020 System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03055832

2020-03

Details and patient eligibility

About

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.

Full description

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

Enrollment

142 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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