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

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03956225
Collaborator
(none)
299
Enrollment
15
Locations
2
Arms
16
Actual Duration (Months)
19.9
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Systane iLux® Dry Eye System
  • Device: LipiFlow® Thermal Pulsation System
N/A

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

Study Type:
Interventional
Actual Enrollment :
299 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Actual Study Start Date :
Jun 25, 2019
Actual Primary Completion Date :
Oct 24, 2020
Actual Study Completion Date :
Oct 24, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: iLux

Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated.

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

Active Comparator: LipiFlow

Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated.

Device: LipiFlow® Thermal Pulsation System
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.

Outcome Measures

Primary Outcome Measures

  1. Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 [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.

Eligibility Criteria

Criteria

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

Exclusion Criteria

  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Alcon Investigator 9083Long BeachCaliforniaUnited States90815
2Alcon Investigator 9081Los AngelesCaliforniaUnited States90013
3Alcon Investigator 9084San DiegoCaliforniaUnited States92122
4Alcon Investigator 5127Panama CityFloridaUnited States32405
5Alcon Investigator 4782Highland ParkIllinoisUnited States60035
6Alcon Investigator 6567PittsburgKansasUnited States66762
7Alcon Investigator 5582LouisvilleKentuckyUnited States40206
8Alcon Investigator 6402MedinaMinnesotaUnited States55340
9Alcon Investigator 1455Kansas CityMissouriUnited States64111
10Alcon Investigator 3828PoughkeepsieNew YorkUnited States12603
11Alcon Investigator 8046GranvilleOhioUnited States43023
12Alcon Investigator 6313PowellOhioUnited States43065
13Alcon Investigator 9082ChambersburgPennsylvaniaUnited States17201
14Alcon Investigator 8028Wichita FallsTexasUnited States76308
15Alcon Investigator 5163KirklandWashingtonUnited States98034

Sponsors and Collaborators

  • Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, Vision Care, Alcon Research

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03956225
Other Study ID Numbers:
  • DEG723-P001
First Posted:
May 20, 2019
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
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 Alcon Research
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsSubjects were recruited from 15 investigative sites located in the United States.
Pre-assignment DetailOf the 299 enrolled subjects, 63 were excluded prior to randomization as screen failures. This reporting group includes all randomized subjects/eyes (236/472).
Arm/Group TitleiLuxLipiFlow
Arm/Group DescriptionSingle treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.
Period Title: Overall Study
STARTED119117
COMPLETED114113
NOT COMPLETED54

Baseline Characteristics

Arm/Group TitleiLuxLipiFlowTotal
Arm/Group DescriptionSingle treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.Total of all reporting groups
Overall Participants119117236
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
58.4
(13.4)
56.2
(14.1)
57.3
(13.8)
Sex: Female, Male (Count of Participants)
Female
94
79%
86
73.5%
180
76.3%
Male
25
21%
31
26.5%
56
23.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
5
4.2%
2
1.7%
7
3%
Not Hispanic or Latino
114
95.8%
115
98.3%
229
97%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
8
6.7%
5
4.3%
13
5.5%
Native Hawaiian or Other Pacific Islander
1
0.8%
0
0%
1
0.4%
Black or African American
6
5%
4
3.4%
10
4.2%
White
103
86.6%
108
92.3%
211
89.4%
More than one race
1
0.8%
0
0%
1
0.4%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
119
100%
117
100%
236
100%

Outcome Measures

1. Primary Outcome
TitleLeast Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
DescriptionMeibomian 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.
Time FrameBaseline, Month 12

Outcome Measure Data

Analysis Population Description
Full Analysis Set with data at visit
Arm/Group TitleiLuxLipiFlow
Arm/Group DescriptionSingle treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.
Measure Participants113113
Measure eyes226226
Least Squares Mean (Standard Error) [score on a scale]
17.4
(1.97)
17.8
(1.98)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iLux, LipiFlow
Comments
Type of Statistical Test Non-Inferiority
Comments Noninferiority in change from baseline in MGS was declared if the lower confidence limit (LCL) was greater than -5.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterLeast Squares Mean Difference
Estimated Value-0.3
Confidence Interval (1-Sided) 95%
-2.2 to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.07
Estimation CommentsStandard Error of the Least Squares Mean is presented. Least squares mean difference (iLux minus LipiFlow). Lower Confidence Limit is presented.

Adverse Events

Time FrameAdverse events (AE's) were collected from time of consent to study exit, up to 12 months.
Adverse Event Reporting Description AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of participants. This analysis population includes all subjects/eyes exposed to any study treatment evaluated in this study.
Arm/Group TitlePretreatmentiLux OculariLux NonocularLipiFlow OcularLipiFlow Nonocular
Arm/Group DescriptionEvents reported in this group occurred prior to exposure to the study treatmentEvents reported in this group occurred in eyes treated with the iLux deviceEvents reported in this group occurred in subjects treated with the iLux deviceEvents reported in this group occurred in eyes treated with the LipiFlow deviceEvents reported in this group occurred in subjects treated with the LipiFlow device
All Cause Mortality
PretreatmentiLux OculariLux NonocularLipiFlow OcularLipiFlow Nonocular
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/236 (0%) 0/238 (0%) 0/119 (0%) 0/234 (0%) 0/117 (0%)
Serious Adverse Events
PretreatmentiLux OculariLux NonocularLipiFlow OcularLipiFlow Nonocular
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/236 (0%) 0/238 (0%) 3/119 (2.5%) 0/234 (0%) 1/117 (0.9%)
Gastrointestinal disorders
Pancreatitis0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Infections and infestations
Cellulitis0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Diverticulitis0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Osteomyelitis0/236 (0%) 0/238 (0%) 0/119 (0%) 0/234 (0%) 1/117 (0.9%)
Pelvic abscess0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Investigations
White blood count increased0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Other (Not Including Serious) Adverse Events
PretreatmentiLux OculariLux NonocularLipiFlow OcularLipiFlow Nonocular
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/236 (0%) 0/238 (0%) 0/119 (0%) 0/234 (0%) 0/117 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

Results Point of Contact

Name/TitleSr. CDMA Project Lead, Ocular Health
OrganizationAlcon Research, LLC
Phone1-888-451-3937
Emailalcon.medinfo@alcon.com
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03956225
Other Study ID Numbers:
  • DEG723-P001
First Posted:
May 20, 2019
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021