iLux Treatment for Meibomian Gland Dysfunction (MGD)

• Sponsor: Tear Film Innovations, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03055650
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arm: 1
• Actual Duration (Months): 2.4
• Patients Per Site: 10
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess changes in meibomian gland function and evaporative dry eye symptoms after treatment with the iLux medical device.

Condition or Disease	Intervention/Treatment	Phase
Evaporative Dry Eye	Device: iLux 2020 System	N/A

Detailed Description

Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: iLux Treatment for Meibomian Gland Dysfunction (MGD)
• Actual Study Start Date: Dec 7, 2015
• Actual Primary Completion Date: Feb 18, 2016
• Actual Study Completion Date: Feb 18, 2016

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Meibomian Gland Secretion (MGS) Total Score [Baseline (Day 0 pretreatment), Week 1, Month 1]

   Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator (MGE 1000) device while viewing the eyelid margin with a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3, for a resultant overall score of 0-45 for 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. Eyes were assessed individually.

2. Change From Baseline in Tear Break-Up Time (TBUT) [Baseline (Day 0 pretreatment), Week 1, Month 1]

   The investigator instilled a drop of fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.

Secondary Outcome Measures

1. Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score [Baseline (Day 0 pretreatment), Week 1, Month 1]

   The Standard Patient Evaluation of Eye Dryness (SPEED) survey is a validated survey that assesses both the frequency and severity of dry eye symptoms. The patient grades the frequency of symptoms (4 items) on a scale from 0 to 3 (0=never; 3=constant) and the severity of each symptom (4 items) on a scale from 0 to 4 (0=no problems; 4=intolerable). Responses to the 8 items are summed to calculate a total score ranging from 0 to 28, where 0=best and 28=worst. A negative change value indicates a perceived improvement in ocular health. Both eyes contributed to the mean.

2. Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score [Baseline (Day 0 pretreatment), Month 1]

   The OSDI is a validated, 12-item questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The patient grades each item on a scale from 0 to 4, where 0 is "None" and 4 is "All of the Time." Responses to the 12 items are summed, and a formula is used to calculate a total score from 0 to 100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value represents a perceived improvement in ocular health. Both eyes contributed to the mean.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Age 18 years and older of any gender or race

2. Provision of written informed consent prior to study participation

3. Willingness and ability to return for all study visits

4. A positive history of self-reported dry eye symptoms for three months prior to the study using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and a score of > 6.

5. Need for regular use of artificial tears, lubricants, or rewetting drops in both eyes

6. Evidence of meibomian gland (MG) obstruction, based on a total meibomian gland secretion score of < 12 out of a maximum score of 45, for 15 glands (5 nasal, 5 medial, 5 temporal) of the lower eyelid of each eye. Glands expressed & graded from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid).

Exclusion Criteria:

1. History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year

2. Ocular trauma or herpetic keratitis within the previous 3 months

3. Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.

4. Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)

5. Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g. retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)

6. Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy

7. Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye

8. Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)

9. Ocular trauma, chemical burns, or limbal stem cell deficiency

10. Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome)

11. Women who are pregnant, nursing, or not utilizing adequate birth control measures

12. Individuals who have either changed the dosing of systemic or ophthalmic medication within the past 30 days prior to screening or who are unable or unwilling to remain on a stable dosing regimen for the duration of the study

13. Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) within 2 months, or topical medications other than non-preserved artificial tears within 2 weeks.

14. Individuals using another investigational device or agent within 30 days of study participation

15. Contact lens wearers or individuals who have worn contact lenses in the last 30 days or anticipate wearing contact lenses during this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TearFilm Investigative Site	Encinitas	California	United States	92924
2	TearFilm Investigative Site	San Diego	California	United States	92122
3	TearFilm Investigative Site	San Diego	California	United States	92128

Sponsors and Collaborators

• Tear Film Innovations, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tear Film Innovations, Inc.
• ClinicalTrials.gov Identifier: NCT03055650
• Other Study ID Numbers: 2020-01
• First Posted: Feb 16, 2017
• Last Update Posted: Nov 12, 2020
• Last Verified: Oct 1, 2020

• 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.: Evaporative Dry Eye (EDE); Meibomian Gland Dysfunction (MGD)
• Additional relevant MeSH terms: Dry Eye Syndromes; Meibomian Gland Dysfunction

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 3 investigative sites located in the United States.
Pre-assignment Detail	This reporting group includes all enrolled participants.

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.9 (11.9)
Sex: Female, Male (Count of Participants)
Female	20 66.7%
Male	10 33.3%
Race/Ethnicity, Customized (participants) [Number]
White	20 66.7%
Native American	4 13.3%
Asian	2 6.7%
Hispanic	2 6.7%
Other	1 3.3%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
Description	Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator (MGE 1000) device while viewing the eyelid margin with a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3, for a resultant overall score of 0-45 for 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. Eyes were assessed individually.
Time Frame	Baseline (Day 0 pretreatment), Week 1, Month 1

Outcome Measure Data

Analysis Population Description

All treated with available data

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Measure Participants	30
Measure eyes	60
Change from Baseline at Week 1	12.3 (7.1)
Change from Baseline at Month 1	14.5 (7.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iLux 2020 System
	Comments	Change from Baseline in Meibomian Gland Secretion Total Score at Week 1
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Statistical significance is set at α = 0.05.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	iLux 2020 System
	Comments	Change from Baseline in Meibomian Gland Secretion Total Score at Month 1
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Statistical significance is set at α = 0.05.

2. Primary Outcome

Title	Change From Baseline in Tear Break-Up Time (TBUT)
Description	The investigator instilled a drop of fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.
Time Frame	Baseline (Day 0 pretreatment), Week 1, Month 1

Outcome Measure Data

Analysis Population Description

All treated with available data

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Measure Participants	30
Measure eyes	60
Change from Baseline at Week 1	3.6 (3.1)
Change from Baseline at Month 1	4.6 (3.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iLux 2020 System
	Comments	Change From Baseline in Tear Break-Up Time (TBUT) at Week 1
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Statistical significance is set at α = 0.05.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	iLux 2020 System
	Comments	Change From Baseline in Tear Break-Up Time (TBUT) at Month 1
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Statistical significance is set at α = 0.05.

3. Secondary Outcome

Title	Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score
Description	The Standard Patient Evaluation of Eye Dryness (SPEED) survey is a validated survey that assesses both the frequency and severity of dry eye symptoms. The patient grades the frequency of symptoms (4 items) on a scale from 0 to 3 (0=never; 3=constant) and the severity of each symptom (4 items) on a scale from 0 to 4 (0=no problems; 4=intolerable). Responses to the 8 items are summed to calculate a total score ranging from 0 to 28, where 0=best and 28=worst. A negative change value indicates a perceived improvement in ocular health. Both eyes contributed to the mean.
Time Frame	Baseline (Day 0 pretreatment), Week 1, Month 1

Outcome Measure Data

Analysis Population Description

All treated with available data

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Measure Participants	30
Change from Baseline at Week 1	-8.6 (7.0)
Change from Baseline at Month 1	-9.1 (6.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iLux 2020 System
	Comments	Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Week 1
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Statistical significance is set at α = 0.025.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	iLux 2020 System
	Comments	Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Month 1
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Statistical significance is set at α = 0.025.

4. Secondary Outcome

Title	Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
Description	The OSDI is a validated, 12-item questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The patient grades each item on a scale from 0 to 4, where 0 is "None" and 4 is "All of the Time." Responses to the 12 items are summed, and a formula is used to calculate a total score from 0 to 100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value represents a perceived improvement in ocular health. Both eyes contributed to the mean.
Time Frame	Baseline (Day 0 pretreatment), Month 1

Outcome Measure Data

Analysis Population Description

All treated with available data

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Measure Participants	30
Mean (Standard Deviation) [score on a scale]	-28.5 (22.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	iLux 2020 System
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments	Statistical significance is set at α = 0.025.

Adverse Events

Time Frame	Adverse event data was collected for each participant from time of enrollment until time of study exit, approximately 4 weeks.
Adverse Event Reporting Description	An adverse event was defined as 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. All subjects exposed to the study treatment were evaluated for adverse events.
Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian Gland Treatment iLux 2020 System: Heating and compression to express clogged meibomian glands
All Cause Mortality
	iLux 2020 System
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	iLux 2020 System
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	iLux 2020 System
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.