Evaporative Dry EyeNCT03055650

iLux Treatment for Meibomian Gland Dysfunction (MGD)

A study testing iLux 2020 System in people with Evaporative Dry Eye, run by Tear Film Innovations, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Evaporative Dry Eye
What is being tested?: iLux 2020 System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 3 sitesUnited States
Study dates: 7 Dec 2015to 18 Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years and older of any gender or race
Provision of written informed consent prior to study participation
Willingness and ability to return for all study visits
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.
Need for regular use of artificial tears, lubricants, or rewetting drops in both eyes
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).

Who cannot join

History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
Ocular trauma or herpetic keratitis within the previous 3 months
Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
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)
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)
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

Show all 15Show fewer

Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye
Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
Ocular trauma, chemical burns, or limbal stem cell deficiency
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)
Women who are pregnant, nursing, or not utilizing adequate birth control measures
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
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.
Individuals using another investigational device or agent within 30 days of study participation
Contact lens wearers or individuals who have worn contact lenses in the last 30 days or anticipate wearing contact lenses during this study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

TearFilm Investigative Site
Encinitas, California, 92924
TearFilm Investigative Site
San Diego, California, 92122
TearFilm Investigative Site
San Diego, California, 92128

Other trials in United States

About this study

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.

Read the 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.

Conditions: Evaporative Dry Eye
Being tested: iLux 2020 System
Keywords: Evaporative Dry Eye (EDE), Meibomian Gland Dysfunction (MGD)
Medical subject headings: Dry Eye Syndromes, Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iLux 2020 SystemDevice
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands

Study groups in NCT03055650
Study group	Role	What they receive
iLux 2020 System	Experimental	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual Receives: Device: iLux 2020 System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
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.
Measured: Baseline (Day 0 pretreatment), Week 1, Month 1
Change From Baseline in Tear Break-Up Time (TBUT)
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.
Measured: Baseline (Day 0 pretreatment), Week 1, Month 1

Secondary outcomes (2)

Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score
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.
Measured: Baseline (Day 0 pretreatment), Week 1, Month 1
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
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.
Measured: Baseline (Day 0 pretreatment), Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 201518 Feb 2016

First posted16 Feb 2017
Study start7 Dec 2015
Primary completion18 Feb 2016
Study completion18 Feb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Evaporative Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03055650
Sponsor's protocol ID: 2020-01
Status last verified: Oct 2020
First submitted: 10 Feb 2017
Last updated: 12 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Schanzlin D, Owen JP, Klein S, Yeh TN, Merchea MM, Bullimore MA. Efficacy of the Systane iLux Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction After 1 Week and 1 Month: A Prospective Study. Eye Contact Lens. 2022 Apr 1;48(4):155-161. doi: 10.1097/ICL.0000000000000847.
PubMed 34620785

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaporative Dry Eye
Dry Eye, Evaporative Dry Eye
Active, not recruitingObservational study
Study for Remote Investigation of Evaporative Dry Eye Disease
Evaporative Loss Dry Eye Disease
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Active, not recruiting
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Evaporative Dry Eye
Not yet recruiting
Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
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All Evaporative Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: iLux Treatment for Meibomian Gland Dysfunction (MGD)
ClinicalTrials.gov ID: NCT03055650
Acronym / sponsor ID: 2020-01
Conditions: Evaporative Dry Eye
Keywords: Evaporative Dry Eye (EDE), Meibomian Gland Dysfunction (MGD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Tear Film Innovations, Inc.Industry (pharma, biotech, devices)
Study start: 7 Dec 2015 (actual)
Primary completion: 18 Feb 2016 (actual)
Study completion: 18 Feb 2016 (actual)
First posted: 16 Feb 2017 (actual)
Results: Posted 12 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
iLux 2020 System	Experimental	Device: iLux 2020 SystemMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18 years and older of any gender or race
Provision of written informed consent prior to study participation
Willingness and ability to return for all study visits
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.
Need for regular use of artificial tears, lubricants, or rewetting drops in both eyes

Key exclusion criteria (15 listed)

History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
Ocular trauma or herpetic keratitis within the previous 3 months
Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
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)
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iLux 2020 SystemMedical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands	Device	iLux 2020 System

Primary outcome

Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
Time frame: 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.
Change From Baseline in Tear Break-Up Time (TBUT)
Time frame: 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.

2 secondary outcomes

Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score
Time frame: Baseline (Day 0 pretreatment), Week 1, Month 1
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
Time frame: Baseline (Day 0 pretreatment), Month 1

Results and safety

Results posted to the registry on 12 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
iLux 2020 System	30	30

Primary outcome: Change From Baseline in Meibomian Gland Secretion (MGS) Total Score

Time frame: Baseline (Day 0 pretreatment), Week 1, Month 1. Mean (Standard Deviation). Unit: score on a scale

Measure	iLux 2020 System n = 30
Change from Baseline at Week 1	12.3 (7.1)
Change from Baseline at Month 1	14.5 (7.9)

iLux 2020 System: p <0.0001, t-test, 2 sided
iLux 2020 System: p <0.0001, t-test, 2 sided

Population analysed: All treated with available data

Primary outcome: Change From Baseline in Tear Break-Up Time (TBUT)

Time frame: Baseline (Day 0 pretreatment), Week 1, Month 1. Mean (Standard Deviation). Unit: seconds

Measure	iLux 2020 System n = 30
Change from Baseline at Week 1	3.6 (3.1)
Change from Baseline at Month 1	4.6 (3.1)

iLux 2020 System: p <0.0001, t-test, 2 sided
iLux 2020 System: p <0.0001, t-test, 2 sided

Population analysed: All treated with available data

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for each participant from time of enrollment until time of study exit, approximately 4 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
iLux 2020 System	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34620785Schanzlin D, Owen JP, Klein S, Yeh TN, Merchea MM, Bullimore MA. Efficacy of the Systane iLux Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction After 1 Week and 1 Month: A Prospective Study. Eye Contact Lens. 2022 Apr 1;48(4):155-161. doi: 10.1097/ICL.0000000000000847.
Individual participant dataSharing planned: No

Related trials for Evaporative Dry Eye

Not yet recruitingPhase 4
Evaporative Dry Eye
Dry Eye, Evaporative Dry Eye
Active, not recruitingObservational study
Study for Remote Investigation of Evaporative Dry Eye Disease
Evaporative Loss Dry Eye Disease
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Active, not recruiting
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Evaporative Dry Eye
Not yet recruiting
Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
Dry Eye Disease, Dry Eye

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing iLux 2020 System in people with Evaporative Dry Eye, run by Tear Film Innovations, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Meibomian Gland Secretion (MGS) Total Score (time frame: Baseline (Day 0 pretreatment), Week 1, Month 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03055650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.