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

Study Overview
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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.

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

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

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: iLux 2020 System
* Device: LipiFlow Pulsation System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iLux 2020 System<br>Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual | Device: iLux 2020 System<br>* Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands<br>|
| Active Comparator: LipiFlow Thermal Pulsation System<br>Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual | Device: LipiFlow Pulsation System<br>* Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 4 in Meibomian Gland Score (MGS) | 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. | Baseline, Week 4 | 
| Change From Baseline to Week 4 in Tear Break-Up Time (TBT) | 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. | Baseline, Week 4 | 
| Incidence (Number) of Device- or Procedure-related Adverse Events | 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. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | 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. | Baseline, Week 4 | 
| Mean Pain Score During 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. | Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment | 
| Mean Discomfort Score During 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. | Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment | 
| Change From Baseline to Post-Treatment in Ocular Surface Staining | 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. | Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment | 
| Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) | 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. | Baseline (Day 0), Immediately Post-Treatment (Day 0) | 
| Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) | 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. | Baseline (Day 0), Immediately Post-Treatment (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iLux, LipiFlow, dry eye, Meibomian Gland Dysfunction, evaporative dry eye