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

Sponsor
Tear Film Innovations, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03055832
Collaborator
(none)
142
Enrollment
7
Locations
2
Arms
5.3
Actual Duration (Months)
20.3
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: iLux 2020 System
  • Device: LipiFlow Pulsation System
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
142 participants
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
Official Title:
Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Actual Study Start Date :
Feb 9, 2017
Actual Primary Completion Date :
Jul 20, 2017
Actual Study Completion Date :
Jul 20, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: iLux 2020 System

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

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

Active Comparator: LipiFlow Thermal Pulsation System

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1TearFilm Investigative SitePhoenixArizonaUnited States85016
2TearFilm Investigative SiteScottsdaleArizonaUnited States95260
3TearFilm Investigative SiteSan DiegoCaliforniaUnited States92122
4TearFilm Investigative SiteCentennialColoradoUnited States80112
5TearFilm Investigative SiteGreenwood VillageColoradoUnited States80111
6TearFilm Investigative SiteChesterfieldMissouriUnited States63017
7TearFilm Investigative SiteKansas CityMissouriUnited States64111

Sponsors and Collaborators

  • Tear Film Innovations, Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Tear Film Innovations, Inc.
ClinicalTrials.gov Identifier:
NCT03055832
Other Study ID Numbers:
  • 2020-03
First Posted:
Feb 16, 2017
Last Update Posted:
May 30, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Tear Film Innovations, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleiLux 2020 SystemLipiFlow Thermal Pulsation System
Arm/Group DescriptionMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User ManualMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Period Title: Baseline
STARTED7171
COMPLETED7171
NOT COMPLETED00
Period Title: Baseline
STARTED7171
COMPLETED7171
NOT COMPLETED00
Period Title: Baseline
STARTED7171
COMPLETED7171
NOT COMPLETED00
Period Title: Baseline
STARTED7171
COMPLETED7071
NOT COMPLETED10
Period Title: Baseline
STARTED7071
COMPLETED7071
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleiLux 2020 SystemLipiFlow Thermal Pulsation SystemTotal
Arm/Group DescriptionMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User ManualMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User ManualTotal of all reporting groups
Overall Participants7171142
Age, Customized (Count of Participants)
Under 18 Years
0
0%
0
0%
0
0%
18 Years and Older
71
100%
71
100%
142
100%
Sex: Female, Male (Count of Participants)
Female
52
73.2%
49
69%
101
71.1%
Male
19
26.8%
22
31%
41
28.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
3
4.2%
1
1.4%
4
2.8%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
4
5.6%
1
1.4%
5
3.5%
White
61
85.9%
68
95.8%
129
90.8%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
3
4.2%
1
1.4%
4
2.8%
Region of Enrollment (participants) [Number]
United States
71
100%
71
100%
142
100%

Outcome Measures

1. Primary Outcome
TitleChange From Baseline to Week 4 in Meibomian Gland Score (MGS)
DescriptionMeibomian 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 FrameBaseline, Week 4

Outcome Measure Data

Analysis Population Description
All randomized and treated patients
Arm/Group TitleiLux Right EyeiLux Left EyeiLux Both EyesLipiFlow Right EyeLipiFlow Left EyeLipiFlow Both Eyes
Arm/Group DescriptionRight Eye of Subjects treated with the iLux 2020 SystemLeft Eye of Subjects treated with the iLux 2020 SystemBoth Eyes of Subjects treated with the iLux 2020 SystemRight Eye of Subjects Treated with the LipiFlow Thermal Pulsation SystemLeft Eye of Subjects treated with Lipiflow Thermal Pulsation SystemBoth Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants707070707171
Measure Eyes70701407071141
Mean (Standard Deviation) [score on a scale]
17.3
(12.1)
18.0
(12.2)
17.7
(12.2)
18.1
(10.8)
16.9
(11.5)
17.5
(11.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux Both Eyes, LipiFlow Both Eyes
Comments
Type of Statistical Test Non-Inferiority
Comments This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions: MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9% TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9% Power that both endpoitns are significant, assuming independence was 0.939^2 = 0.882 or 88.2% power.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterMean Difference (Net)
Estimated Value-0.13
Confidence Interval (2-Sided) 95%
-3.82 to 3.56
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.88
Estimation Comments
2. Primary Outcome
TitleChange From Baseline to Week 4 in Tear Break-Up Time (TBT)
DescriptionTear 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 FrameBaseline, Week 4

Outcome Measure Data

Analysis Population Description
All randomized and treated patients
Arm/Group TitleiLux Right EyeiLux Left EyeiLux Both EyesLipiFlow Right EyeLipiFlow Left EyeLipiFlow Both Eyes
Arm/Group DescriptionRight Eye of Subjects treated with the iLux 2020 SystemLeft Eye of Subjects treated with the iLux 2020 SystemBoth Eyes of Subjects treated with the iLux 2020 SystemRight Eye of Subjects Treated with the LipiFlow Thermal Pulsation SystemLeft Eye of Subjects treated with Lipiflow Thermal Pulsation SystemBoth Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants707070717171
Measure Eyes70701407171142
Mean (Standard Deviation) [seconds]
2.86
(3.72)
2.73
(3.72)
2.79
(3.66)
2.69
(3.31)
2.61
(3.22)
2.65
(3.25)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux Both Eyes, LipiFlow Both Eyes
Comments
Type of Statistical Test Non-Inferiority
Comments This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions: MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9% TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9% Power that both endpoitns are significant, assuming independence was 0.939^2 = 0.882 or 88.2% power.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterMean Difference (Net)
Estimated Value0.10
Confidence Interval (2-Sided) 95%
-0.97 to 1.16
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.54
Estimation Comments
3. Primary Outcome
TitleIncidence (Number) of Device- or Procedure-related Adverse Events
DescriptionThe 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 FrameWeek 4

Outcome Measure Data

Analysis Population Description
All randomized and treated patients
Arm/Group TitleiLux 2020 SystemLipiFlow Thermal Pulsation System
Arm/Group DescriptionMeibomian Gland Treatment iLux 2020 System: Heating and compression to express clogged meibomian glandsMeibomian Gland Treatment LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands
Measure Participants7071
Number [Adverse event]
4
0
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux Right Eye, iLux Left Eye
Comments
Type of Statistical Test Other
Comments A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms.
Statistical Test of Hypothesisp-Value0.12
Comments
MethodFisher Exact
Comments
4. Secondary Outcome
TitleChange From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)
DescriptionThe 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 FrameBaseline, Week 4

Outcome Measure Data

Analysis Population Description
All randomized and treated patients
Arm/Group TitleiLux All QuestionsiLux Vision QuestionsiLux Ocular QuestionsiLux Trigger QuestionsLipiFlow All QuestionsLipiFlow Vision QuestionsLipiFlow Ocular QuestionsLipiFlow Trigger Questions
Arm/Group DescriptionAll OSDI questions in Subjects treated with the iLux 2020 SystemOSDI Questions 1-5 in Subjects Treated with the iLux 2020 SystemOSDI questions 6-9 in Subjects treated with the iLux 2020 SystemOSDI questions 10-12 in Subjects treated with the iLux 2020 SystemAll OSDI questions (1-12) in Subjects treated with the LipiFlow Thermal Pulsation SystemOSDI Questions 1-5 in Subjects treated with the LipiFlow Thermal Pulsation SystemOSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation SystemOSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants7070707071717071
Mean (Standard Deviation) [score on a scale]
-31.0
(18.4)
-27.3
(19.7)
-30.9
(25.9)
-37.0
(30.6)
-28.0
(22.8)
-24.9
(20.0)
-27.5
(28.4)
-34.4
(34.7)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux Right Eye, LipiFlow Left Eye
Comments All questions
Type of Statistical Test Non-Inferiority
Comments A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterMean Difference (Net)
Estimated Value-3.08
Confidence Interval (2-Sided) 95%
-8.75 to 2.59
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.89
Estimation Comments
5. Secondary Outcome
TitleMean Pain Score During Treatment
DescriptionThe 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 FrameBaseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment

Outcome Measure Data

Analysis Population Description
All randomized and treated patients
Arm/Group TitleiLux Right EyeiLux Left EyeiLux Both EyesLipiFlow Right EyeLipiFlow Left EyeLipiFlow Both Eyes
Arm/Group DescriptionRight Eye of Subjects treated with the iLux 2020 SystemLeft Eye of Subjects treated with the iLux 2020 SystemBoth Eyes of Subjects treated with the iLux 2020 SystemRight Eye of Subjects Treated with the LipiFlow Thermal Pulsation SystemLeft Eye of Subjects treated with Lipiflow Thermal Pulsation SystemBoth Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants717171697070
Measure Eyes71711426970139
Baseline (Day 0)
34.4
(28.6)
34.0
(28.0)
34.2
(28.2)
30.8
(26.4)
32.6
(27.6)
31.7
(27.0)
Immediately Post-Treatment (Day 0)
25.2
(25.1)
23.6
(23.7)
24.4
(24.3)
10.2
(14.6)
10.1
(13.8)
10.1
(14.1)
Day 1 Post-Treatment
12.0
(15.7)
13.0
(17.0)
12.5
(16.3)
11.8
(17.8)
11.5
(16.9)
11.7
(17.3)
6. Secondary Outcome
TitleMean Discomfort Score During Treatment
DescriptionThe 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 FrameBaseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment

Outcome Measure Data

Analysis Population Description
All randomized and treated patients
Arm/Group TitleiLux Right EyeiLux Left EyeiLux Both EyesLipiFlow Right EyeLipiFlow Left EyeLipiFlow Both Eyes
Arm/Group DescriptionRight Eye of Subjects treated with the iLux 2020 SystemLeft Eye of Subjects treated with the iLux 2020 SystemBoth Eyes of Subjects treated with the iLux 2020 SystemRight Eye of Subjects Treated with the LipiFlow Thermal Pulsation SystemLeft Eye of Subjects treated with Lipiflow Thermal Pulsation SystemBoth Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants717171697070
Measure Eyes71711426970139
Baseline (Day 0)
56.3
(22.3)
55.9
(21.8)
56.1
(22.0)
52.1
(23.6)
52.6
(24.0)
52.3
(23.6)
Immediately Post-Treatment (Day 0)
38.9
(24.7)
36.7
(22.5)
37.8
(23.6)
22.3
(21.2)
23.7
(21.6)
23.0
(21.3)
Day 1 Post-Treatment
23.5
(22.5)
23.7
(22.4)
23.6
(22.4)
24.7
(24.2)
24.4
(23.4)
24.5
(23.7)
7. Secondary Outcome
TitleChange From Baseline to Post-Treatment in Ocular Surface Staining
DescriptionCorneal 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 FrameBaseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleiLux Right EyeiLux Left EyeiLux Both EyesLipiFlow Right EyeLipiFlow Left EyeLipiFlow Both Eyes
Arm/Group DescriptionRight Eye of Subjects treated with the iLux 2020 SystemLeft Eye of Subjects treated with the iLux 2020 SystemBoth Eyes of Subjects treated with the iLux 2020 SystemRight Eye of Subjects Treated with the LipiFlow Thermal Pulsation SystemLeft Eye of Subjects treated with Lipiflow Thermal Pulsation SystemBoth Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants717171707070
Measure Eyes71711427070140
Change from Baseline to Immediately Post-Treatment
0.6
(1.7)
0.6
(1.7)
0.6
(1.7)
0.5
(1.6)
0.4
(1.5)
0.4
(1.6)
Change from Baseline to Day 1 Post-Treatment
-0.9
(1.8)
-1.0
(2.0)
-0.9
(1.9)
-0.9
(1.5)
-1.2
(1.9)
-1.1
(1.7)
8. Secondary Outcome
TitleChange From Baseline to Post-Treatment in Intraocular Pressure (IOP)
DescriptionIOP (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 FrameBaseline (Day 0), Immediately Post-Treatment (Day 0)

Outcome Measure Data

Analysis Population Description
All randomized and treated patients
Arm/Group TitleiLux Right EyeiLux Left EyeiLux Both EyesLipiFlow Right EyeLipiFlow Left EyeLipiFlow Both Eyes
Arm/Group DescriptionRight Eye of Subjects treated with the iLux 2020 SystemLeft Eye of Subjects treated with the iLux 2020 SystemBoth Eyes of Subjects treated with the iLux 2020 SystemRight Eye of Subjects Treated with the LipiFlow Thermal Pulsation SystemLeft Eye of Subjects treated with Lipiflow Thermal Pulsation SystemBoth Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants717171696969
Measure Eyes71711426969138
Mean (Standard Deviation) [mmHg]
0.04
(1.44)
-0.07
(1.54)
-0.01
(1.49)
0.07
(1.94)
-0.04
(1.79)
0.01
(1.86)
9. Secondary Outcome
TitleChange From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)
DescriptionVisual 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 FrameBaseline (Day 0), Immediately Post-Treatment (Day 0)

Outcome Measure Data

Analysis Population Description
All randomized and treated patients
Arm/Group TitleiLux Right EyeiLux Left EyeiLux Both EyesLipiFlow Right EyeLipiFlow Left EyeLipiFlow Both Eyes
Arm/Group DescriptionRight Eye of Subjects treated with the iLux 2020 SystemLeft Eye of Subjects treated with the iLux 2020 SystemBoth Eyes of Subjects treated with the iLux 2020 SystemRight Eye of Subjects Treated with the LipiFlow Thermal Pulsation SystemLeft Eye of Subjects treated with Lipiflow Thermal Pulsation SystemBoth Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants717171707070
Measure Eyes71711427070140
Mean (Standard Deviation) [logMAR]
0.02
(0.08)
0.05
(0.11)
0.03
(0.09)
0.02
(0.11)
0.02
(0.07)
0.02
(0.09)

Adverse Events

Time Frame4 weeks
Adverse Event Reporting Description Any untoward and unintended sign, symptom or disease temporally associated with the use of an investigational drug or device, or other protocol-imposed intervention, regardless of the suspected cause. Chronic but stable conditions or diseases are not AEs. Changes in a chronic condition or disease consistent with natural disease progression are not AEs. AEs were assessed during procedure, immediately post-procedure, 1 day, 2 weeks, & 4 weeks post-procedure.
Arm/Group TitleiLux 2020 SystemLipiFlow Thermal Pulsation System
Arm/Group DescriptionMeibomian Gland Treatment iLux 2020 System: Heating and compression to express clogged meibomian glandsMeibomian Gland Treatment LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands
All Cause Mortality
iLux 2020 SystemLipiFlow Thermal Pulsation System
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/71 (0%) 0/71 (0%)
Serious Adverse Events
iLux 2020 SystemLipiFlow Thermal Pulsation System
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/71 (0%) 0/71 (0%)
Other (Not Including Serious) Adverse Events
iLux 2020 SystemLipiFlow Thermal Pulsation System
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/71 (7%) 4/71 (5.6%)
Eye disorders
Other5/71 (7%) 54/71 (5.6%) 4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleRob Thornhill
OrganizationTearFilm Innovations, Inc.
Phone844-458-9776
Emailrthornhill@tearfilm.com
Responsible Party:
Tear Film Innovations, Inc.
ClinicalTrials.gov Identifier:
NCT03055832
Other Study ID Numbers:
  • 2020-03
First Posted:
Feb 16, 2017
Last Update Posted:
May 30, 2019
Last Verified:
May 1, 2019