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

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iLux 2020 System
LipiFlow Pulsation System
Sponsored by
Tear Film Innovations, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring iLux, LipiFlow, dry eye, Meibomian Gland Dysfunction, evaporative dry eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • TearFilm Investigative Site
  • TearFilm Investigative Site
  • TearFilm Investigative Site
  • TearFilm Investigative Site
  • TearFilm Investigative Site
  • TearFilm Investigative Site
  • TearFilm Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iLux 2020 System

LipiFlow Thermal Pulsation System

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 10, 2017
Last Updated
April 10, 2023
Sponsor
Tear Film Innovations, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03055832
Brief Title
Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Official Title
Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tear Film Innovations, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
Keywords
iLux, LipiFlow, dry eye, Meibomian Gland Dysfunction, evaporative dry eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Meibomian gland score will be assessed by a masked rater
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iLux 2020 System
Arm Type
Experimental
Arm Description
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Arm Title
LipiFlow Thermal Pulsation System
Arm Type
Active Comparator
Arm Description
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Intervention Type
Device
Intervention Name(s)
iLux 2020 System
Intervention Description
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
Intervention Type
Device
Intervention Name(s)
LipiFlow Pulsation System
Intervention Description
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Primary Outcome Measure Information:
Title
Change From Baseline to Week 4 in Meibomian Gland Score (MGS)
Description
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.
Time Frame
Baseline, Week 4
Title
Change From Baseline to Week 4 in Tear Break-Up Time (TBT)
Description
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.
Time Frame
Baseline, Week 4
Title
Incidence (Number) of Device- or Procedure-related Adverse Events
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
Baseline, Week 4
Title
Mean Pain Score During Treatment
Description
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.
Time Frame
Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Title
Mean Discomfort Score During Treatment
Description
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.
Time Frame
Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Title
Change From Baseline to Post-Treatment in Ocular Surface Staining
Description
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.
Time Frame
Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Title
Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)
Description
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.
Time Frame
Baseline (Day 0), Immediately Post-Treatment (Day 0)
Title
Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)
Description
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.
Time Frame
Baseline (Day 0), Immediately Post-Treatment (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TearFilm Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
TearFilm Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
95260
Country
United States
Facility Name
TearFilm Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
TearFilm Investigative Site
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
TearFilm Investigative Site
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
TearFilm Investigative Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
TearFilm Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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