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

Not Applicable

Completed

Conditions: Meibomian Gland Dysfunction

Interventions: Device: iLux 2020 System
Device: LipiFlow Pulsation System

Registration Number: NCT03055832

Lead Sponsor: Tear Film Innovations, Inc.

Brief Summary: 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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 142

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iLux 2020 System	iLux 2020 System	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
LipiFlow Thermal Pulsation System	LipiFlow Pulsation System	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in Tear Break-Up Time (TBT)	Baseline, Week 4	Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBT. A positive change value represents a lengthening in the tear break-up time and greater comfort.
Incidence (Number) of Device- or Procedure-related Adverse Events	Week 4	The number of device- or procedure-related adverse events was calculated, including changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion (eyelid rolled inward) or ectropion (eyelid sagging outward) or loss of lash integrity.
Change From Baseline to Week 4 in Meibomian Gland Score (MGS)	Baseline, Week 4	Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)	Baseline, Week 4	The Ocular Surface Disease Index (OSDI) is a 12-item, patient-reported outcome questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. Each item is scored on a 0-4 Likert-type scale, where 0 is "None" and 4 is "All of the Time." The OSDI is calculated as the (sum of scores) x 25 / (# of questions answered), for a resultant overall score of 0-100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value indicates an improvement.
Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)	Baseline (Day 0), Immediately Post-Treatment (Day 0)	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A negative change value indicates an improvement. No formal hypothesis testing was pre-specified for this endpoint.
Change From Baseline to Post-Treatment in Ocular Surface Staining	Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment	Corneal staining was assessed by the examiner using the National Eye Institute corneal grading scale and a slit-lamp. Each of the 5 corneal regions (superior, inferior, central, temporal, \& central), was graded on a 0-3 scale, where 0=normal-no staining (best); 1=mild-superficial stippling micropunctate staining; 2=moderate-macropunctate staining with some coalescent areas; and 3=severe-numerous coalescent macropunctate areas and/or patches (worst). The scores were summed for each eye, and an overall corneal staining score was computed as the average of the sum from both eyes. Overall scores ranged between 0-15, with higher change value indicating greater damage to the corneal surface. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.
Mean Pain Score During Treatment	Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment	The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no pain, 100 = maximum pain) at the point that indicated the pain in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. A score a 20 was associated with a description of "hurts a little". Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.
Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)	Baseline (Day 0), Immediately Post-Treatment (Day 0)	Visual acuity was assessed with spectacles or other visual corrective devices in place using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Results are presented in logarithm of the minimum angle of resolution (logMAR) with 0.2 in logMAR corresponding to 10 ETDRS letters read. A lower logMAR change value indicates an improvement in visual acuity. No formal hypothesis testing was pre-specified for this endpoint.
Mean Discomfort Score During Treatment	Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment	The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no discomfort, 100 = maximum discomfort) at the point that indicated the discomfort in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.