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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055832
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : May 20, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Tear Film Innovations, Inc.

Tracking Information
First Submitted Date  ICMJE February 10, 2017
First Posted Date  ICMJE February 16, 2017
Results First Submitted Date  ICMJE April 22, 2019
Results First Posted Date  ICMJE May 20, 2019
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE February 9, 2017
Actual Primary Completion Date July 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Change From Baseline to Week 4 in Meibomian Gland Score (MGS) [ Time Frame: 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.
  • Change From Baseline to Week 4 in Tear Break-Up Time (TBT) [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) [ Time Frame: 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.
  • Mean Pain Score During Treatment [ Time Frame: 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.
  • Mean Discomfort Score During Treatment [ Time Frame: 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.
  • Change From Baseline to Post-Treatment in Ocular Surface Staining [ Time Frame: 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.
  • Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) [ Time Frame: 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 Best Spectacle-Corrected Visual Acuity (BSCVA) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Official Title  ICMJE Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Meibomian gland score will be assessed by a masked rater
Primary Purpose: Treatment
Condition  ICMJE Meibomian Gland Dysfunction
Intervention  ICMJE
  • Device: iLux 2020 System
    Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
  • 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
Study Arms  ICMJE
  • Experimental: iLux 2020 System
    Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
    Intervention: Device: iLux 2020 System
  • Active Comparator: LipiFlow Thermal Pulsation System
    Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
    Intervention: Device: LipiFlow Pulsation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
142
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 20, 2017
Actual Primary Completion Date July 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055832
Other Study ID Numbers  ICMJE 2020-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tear Film Innovations, Inc.
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Tear Film Innovations, Inc.
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tear Film Innovations, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP