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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-09

Study Completion Date

2017-07-20

Brief Summary

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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.

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Detailed Description

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

Conditions

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Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Meibomian gland score will be assessed by a masked rater

Study Groups

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iLux 2020 System

Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual

Group Type EXPERIMENTAL

iLux 2020 System

Intervention Type DEVICE

Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands

LipiFlow Thermal Pulsation System

Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual

Group Type ACTIVE_COMPARATOR

LipiFlow Pulsation System

Intervention Type DEVICE

Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content

Interventions

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iLux 2020 System

Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands

Intervention Type DEVICE

LipiFlow Pulsation System

Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No