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)
• Enrollment: 142
• Locations: 7
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site: 20.3
• Patients Per Site Per Month: 3.8

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 Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	TearFilm Investigative Site	Phoenix	Arizona	United States	85016
2	TearFilm Investigative Site	Scottsdale	Arizona	United States	95260
3	TearFilm Investigative Site	San Diego	California	United States	92122
4	TearFilm Investigative Site	Centennial	Colorado	United States	80112
5	TearFilm Investigative Site	Greenwood Village	Colorado	United States	80111
6	TearFilm Investigative Site	Chesterfield	Missouri	United States	63017
7	TearFilm Investigative Site	Kansas City	Missouri	United States	64111

Sponsors and Collaborators

• Tear Film Innovations, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 3, 2019

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.: iLux; LipiFlow; dry eye; Meibomian Gland Dysfunction; evaporative dry eye
• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

Participant Flow

Arm/Group Title	iLux 2020 System	LipiFlow Thermal Pulsation System
Arm/Group 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
Period Title: Baseline
STARTED	71	71
COMPLETED	71	71
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	71	71
COMPLETED	71	71
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	71	71
COMPLETED	71	71
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	71	71
COMPLETED	70	71
NOT COMPLETED	1	0
Period Title: Baseline
STARTED	70	71
COMPLETED	70	71
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	iLux 2020 System	LipiFlow Thermal Pulsation System	Total
Arm/Group 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	Total of all reporting groups
Overall Participants	71	71	142
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

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

Outcome Measure Data

Analysis Population Description

All randomized and treated patients

Arm/Group Title	iLux Right Eye	iLux Left Eye	iLux Both Eyes	LipiFlow Right Eye	LipiFlow Left Eye	LipiFlow Both Eyes
Arm/Group Description	Right Eye of Subjects treated with the iLux 2020 System	Left Eye of Subjects treated with the iLux 2020 System	Both Eyes of Subjects treated with the iLux 2020 System	Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System	Left Eye of Subjects treated with Lipiflow Thermal Pulsation System	Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants	70	70	70	70	71	71
Measure Eyes	70	70	140	70	71	141
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 Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean 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

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

Outcome Measure Data

Analysis Population Description

All randomized and treated patients

Arm/Group Title	iLux Right Eye	iLux Left Eye	iLux Both Eyes	LipiFlow Right Eye	LipiFlow Left Eye	LipiFlow Both Eyes
Arm/Group Description	Right Eye of Subjects treated with the iLux 2020 System	Left Eye of Subjects treated with the iLux 2020 System	Both Eyes of Subjects treated with the iLux 2020 System	Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System	Left Eye of Subjects treated with Lipiflow Thermal Pulsation System	Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants	70	70	70	71	71	71
Measure Eyes	70	70	140	71	71	142
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 Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.10
	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

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

Outcome Measure Data

Analysis Population Description

All randomized and treated patients

Arm/Group Title	iLux 2020 System	LipiFlow Thermal Pulsation System
Arm/Group Description	Meibomian Gland Treatment iLux 2020 System: Heating and compression to express clogged meibomian glands	Meibomian Gland Treatment LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands
Measure Participants	70	71
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 Hypothesis	p-Value	0.12
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All randomized and treated patients

Arm/Group Title	iLux All Questions	iLux Vision Questions	iLux Ocular Questions	iLux Trigger Questions	LipiFlow All Questions	LipiFlow Vision Questions	LipiFlow Ocular Questions	LipiFlow Trigger Questions
Arm/Group Description	All OSDI questions in Subjects treated with the iLux 2020 System	OSDI Questions 1-5 in Subjects Treated with the iLux 2020 System	OSDI questions 6-9 in Subjects treated with the iLux 2020 System	OSDI questions 10-12 in Subjects treated with the iLux 2020 System	All OSDI questions (1-12) in Subjects treated with the LipiFlow Thermal Pulsation System	OSDI Questions 1-5 in Subjects treated with the LipiFlow Thermal Pulsation System	OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System	OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants	70	70	70	70	71	71	70	71
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 Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean 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

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

Outcome Measure Data

Analysis Population Description

All randomized and treated patients

Arm/Group Title	iLux Right Eye	iLux Left Eye	iLux Both Eyes	LipiFlow Right Eye	LipiFlow Left Eye	LipiFlow Both Eyes
Arm/Group Description	Right Eye of Subjects treated with the iLux 2020 System	Left Eye of Subjects treated with the iLux 2020 System	Both Eyes of Subjects treated with the iLux 2020 System	Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System	Left Eye of Subjects treated with Lipiflow Thermal Pulsation System	Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants	71	71	71	69	70	70
Measure Eyes	71	71	142	69	70	139
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

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

Outcome Measure Data

Analysis Population Description

All randomized and treated patients

Arm/Group Title	iLux Right Eye	iLux Left Eye	iLux Both Eyes	LipiFlow Right Eye	LipiFlow Left Eye	LipiFlow Both Eyes
Arm/Group Description	Right Eye of Subjects treated with the iLux 2020 System	Left Eye of Subjects treated with the iLux 2020 System	Both Eyes of Subjects treated with the iLux 2020 System	Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System	Left Eye of Subjects treated with Lipiflow Thermal Pulsation System	Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants	71	71	71	69	70	70
Measure Eyes	71	71	142	69	70	139
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

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iLux Right Eye	iLux Left Eye	iLux Both Eyes	LipiFlow Right Eye	LipiFlow Left Eye	LipiFlow Both Eyes
Arm/Group Description	Right Eye of Subjects treated with the iLux 2020 System	Left Eye of Subjects treated with the iLux 2020 System	Both Eyes of Subjects treated with the iLux 2020 System	Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System	Left Eye of Subjects treated with Lipiflow Thermal Pulsation System	Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants	71	71	71	70	70	70
Measure Eyes	71	71	142	70	70	140
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

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)

Outcome Measure Data

Analysis Population Description

All randomized and treated patients

Arm/Group Title	iLux Right Eye	iLux Left Eye	iLux Both Eyes	LipiFlow Right Eye	LipiFlow Left Eye	LipiFlow Both Eyes
Arm/Group Description	Right Eye of Subjects treated with the iLux 2020 System	Left Eye of Subjects treated with the iLux 2020 System	Both Eyes of Subjects treated with the iLux 2020 System	Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System	Left Eye of Subjects treated with Lipiflow Thermal Pulsation System	Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants	71	71	71	69	69	69
Measure Eyes	71	71	142	69	69	138
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

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)

Outcome Measure Data

Analysis Population Description

All randomized and treated patients

Arm/Group Title	iLux Right Eye	iLux Left Eye	iLux Both Eyes	LipiFlow Right Eye	LipiFlow Left Eye	LipiFlow Both Eyes
Arm/Group Description	Right Eye of Subjects treated with the iLux 2020 System	Left Eye of Subjects treated with the iLux 2020 System	Both Eyes of Subjects treated with the iLux 2020 System	Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System	Left Eye of Subjects treated with Lipiflow Thermal Pulsation System	Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
Measure Participants	71	71	71	70	70	70
Measure Eyes	71	71	142	70	70	140
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 Frame	4 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 Title	iLux 2020 System		LipiFlow Thermal Pulsation System
Arm/Group Description	Meibomian Gland Treatment iLux 2020 System: Heating and compression to express clogged meibomian glands		Meibomian Gland Treatment LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands
All Cause Mortality
	iLux 2020 System		LipiFlow Thermal Pulsation System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/71 (0%)
Serious Adverse Events
	iLux 2020 System		LipiFlow Thermal Pulsation System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/71 (0%)
Other (Not Including Serious) Adverse Events
	iLux 2020 System		LipiFlow Thermal Pulsation System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/71 (7%)		4/71 (5.6%)
Eye disorders
Other	5/71 (7%)	5	4/71 (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.