Meibomian Gland DysfunctionNCT03956225

Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study

A study testing Systane iLux® Dry Eye System and LipiFlow® Thermal Pulsation System in people with Meibomian Gland Dysfunction and Evaporative Dry Eye Disease, run by Alcon Research at 15 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 post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Meibomian Gland Dysfunction, Evaporative Dry Eye Disease
What is being tested?: Systane iLux® Dry Eye System and LipiFlow® Thermal Pulsation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 299 participants
Where: 15 sitesUnited States
Study dates: 25 Jun 2019to 24 Oct 2020
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

Understand and sign an Informed Consent document;
Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit;
Agree not to wear contact lenses for the duration of the study;
Other protocol-specified inclusion criteria may apply.

Who cannot join

History of eye surgery, as specified in the protocol;
Eye infection or inflammation, as specified in the protocol;
Eyelid abnormalities; eyelid tattoos;
Treated with LipiFlow or iLux in either eye in the last 12 months;
Contact lens wear within the 1 month prior to Screening;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Alcon Investigator 9082
Chambersburg, Pennsylvania, 17201
Alcon Investigator 8046
Granville, Ohio, 43023
Alcon Investigator 4782
Highland Park, Illinois, 60035
Alcon Investigator 1455
Kansas City, Missouri, 64111
Alcon Investigator 5163
Kirkland, Washington, 98034
Alcon Investigator 9083
Long Beach, California, 90815
Alcon Investigator 9081
Los Angeles, California, 90013
Alcon Investigator 5582
Louisville, Kentucky, 40206
Alcon Investigator 6402
Medina, Minnesota, 55340
Alcon Investigator 5127
Panama City, Florida, 32405
Alcon Investigator 6567
Pittsburg, Kansas, 66762
Alcon Investigator 3828
Poughkeepsie, New York, 12603
Alcon Investigator 6313
Powell, Ohio, 43065
Alcon Investigator 9084
San Diego, California, 92122
Alcon Investigator 8028
Wichita Falls, Texas, 76308

Other trials in United States

About this study

The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.

Read the detailed description

Subjects will be expected to attend a total of 8 study visits, including Screening/Baseline, Treatment, and follow-up visits at Week 2 and Months 1, 3, 6, 9, and 12.

Conditions: Meibomian Gland Dysfunction, Evaporative Dry Eye Disease
Being tested: Systane iLux® Dry Eye System, LipiFlow® Thermal Pulsation System
Keywords: Dry eye, MGD
Medical subject headings: Meibomian Gland Dysfunction, Dry Eye Syndromes

What participants receive

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

Systane iLux® Dry Eye SystemDevice
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
LipiFlow® Thermal Pulsation SystemDevice
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.

Study groups in NCT03956225
Study group	Role	What they receive
iLux	Experimental	Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated. Receives: Device: Systane iLux® Dry Eye System
LipiFlow	Active comparator	Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated. Receives: Device: LipiFlow® Thermal Pulsation System

What is being measured

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

Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
Meibomian glands on the eyelids were assessed by the examiner using a Meibomian Gland Evaluator and a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring was follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function.
Measured: Baseline, Month 12

Timeline

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

25 Jun 201924 Oct 2020

First posted20 May 2019
Study start25 Jun 2019
Primary completion24 Oct 2020
Study completion24 Oct 2020

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 Meibomian Gland DysfunctionStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03956225
Sponsor's protocol ID: DEG723-P001
Status last verified: Sep 2021
First submitted: 17 May 2019
Last updated: 8 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Wesley G, Bickle K, Downing J, Fisher B, Greene B, Heinrich C, Kading D, Kannarr S, Miller J, Modi S, Ludwick D, Tauber J, Srinivasan S, Manoj V. Comparison of Two Thermal Pulsation Systems in the Treatment of Meibomian Gland Dysfunction: A Randomized, Multicenter Study. Optom Vis Sci. 2022 Apr 1;99(4):323-332. doi: 10.1097/OPX.0000000000001892.
PubMed 35383732

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

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
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TearCare in Young Adults
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Autologous Serum Obtained by a Closed-Circuit Collection Device
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Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
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Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
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All Meibomian Gland Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
ClinicalTrials.gov ID: NCT03956225
Acronym / sponsor ID: DEG723-P001
Conditions: Meibomian Gland Dysfunction, Evaporative Dry Eye Disease
Keywords: Dry eye, MGD
Study type: Interventional
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 25 Jun 2019 (actual)
Primary completion: 24 Oct 2020 (actual)
Study completion: 24 Oct 2020 (actual)
First posted: 20 May 2019 (actual)
Results: Posted 8 Oct 2021

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 post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.

Detailed description

Subjects will be expected to attend a total of 8 study visits, including Screening/Baseline, Treatment, and follow-up visits at Week 2 and Months 1, 3, 6, 9, and 12.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
iLux	Experimental	Device: Systane iLux® Dry Eye SystemSingle treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated.
LipiFlow	Active comparator	Device: LipiFlow® Thermal Pulsation SystemSingle treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated.

Who may qualify

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

Key inclusion criteria (4 listed)

Understand and sign an Informed Consent document;
Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit;
Agree not to wear contact lenses for the duration of the study;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (6 listed)

History of eye surgery, as specified in the protocol;
Eye infection or inflammation, as specified in the protocol;
Eyelid abnormalities; eyelid tattoos;
Treated with LipiFlow or iLux in either eye in the last 12 months;
Contact lens wear within the 1 month prior to Screening;

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
Systane iLux® Dry Eye SystemCommercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.	Device	iLux
LipiFlow® Thermal Pulsation SystemCommercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.	Device	LipiFlow

Primary outcome

Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
Time frame: Baseline, Month 12
Meibomian glands on the eyelids were assessed by the examiner using a Meibomian Gland Evaluator and a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring was follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function.

Results and safety

Results posted to the registry on 8 Oct 2021, 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	119	114
LipiFlow	117	113

Primary outcome: Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12

Time frame: Baseline, Month 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	iLux n = 113	LipiFlow n = 113
Value	17.4 (1.97)	17.8 (1.98)

iLux vs LipiFlow: Least Squares Mean Difference: -0.3, Mixed effects repeated measures

Population analysed: Full Analysis Set with data at visit

Adverse events

Time frame: Adverse events (AE's) were collected from time of consent to study exit, up to 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 236 (0%)	0 of 236 (0%)	0 of 236
iLux Ocular	0 of 238 (0%)	0 of 238 (0%)	0 of 238
iLux Nonocular	3 of 119 (2.5%)	0 of 119 (0%)	0 of 119
LipiFlow Ocular	0 of 234 (0%)	0 of 234 (0%)	0 of 234
LipiFlow Nonocular	1 of 117 (0.9%)	0 of 117 (0%)	0 of 117

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35383732Wesley G, Bickle K, Downing J, Fisher B, Greene B, Heinrich C, Kading D, Kannarr S, Miller J, Modi S, Ludwick D, Tauber J, Srinivasan S, Manoj V. Comparison of Two Thermal Pulsation Systems in the Treatment of Meibomian Gland Dysfunction: A Randomized, Multicenter Study. Optom Vis Sci. 2022 Apr 1;99(4):323-332. doi: 10.1097/OPX.0000000000001892.
Individual participant dataSharing planned: No

Related trials for Meibomian Gland Dysfunction

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease

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.

Clinical Trial Lead, Vision Care study director

Alcon Research

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 6 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 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 8 Oct 2021). 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?

Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 (time frame: Baseline, Month 12). 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 NCT03956225, 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 8 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.