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
15
2
16
19.9
1.2

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 Disease Intervention/Treatment Phase
  • 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

Arm Intervention/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

Site City State Country Postal Code
1 Alcon Investigator 9083 Long Beach California United States 90815
2 Alcon Investigator 9081 Los Angeles California United States 90013
3 Alcon Investigator 9084 San Diego California United States 92122
4 Alcon Investigator 5127 Panama City Florida United States 32405
5 Alcon Investigator 4782 Highland Park Illinois United States 60035
6 Alcon Investigator 6567 Pittsburg Kansas United States 66762
7 Alcon Investigator 5582 Louisville Kentucky United States 40206
8 Alcon Investigator 6402 Medina Minnesota United States 55340
9 Alcon Investigator 1455 Kansas City Missouri United States 64111
10 Alcon Investigator 3828 Poughkeepsie New York United States 12603
11 Alcon Investigator 8046 Granville Ohio United States 43023
12 Alcon Investigator 6313 Powell Ohio United States 43065
13 Alcon Investigator 9082 Chambersburg Pennsylvania United States 17201
14 Alcon Investigator 8028 Wichita Falls Texas United States 76308
15 Alcon Investigator 5163 Kirkland Washington United States 98034

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 Details Subjects were recruited from 15 investigative sites located in the United States.
Pre-assignment Detail Of 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 Title iLux LipiFlow
Arm/Group Description Single 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
STARTED 119 117
COMPLETED 114 113
NOT COMPLETED 5 4

Baseline Characteristics

Arm/Group Title iLux LipiFlow Total
Arm/Group Description Single 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 Participants 119 117 236
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
Title Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
Description 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.
Time Frame Baseline, Month 12

Outcome Measure Data

Analysis Population Description
Full Analysis Set with data at visit
Arm/Group Title iLux LipiFlow
Arm/Group Description Single 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 Participants 113 113
Measure eyes 226 226
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 Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Least 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 Comments Standard Error of the Least Squares Mean is presented. Least squares mean difference (iLux minus LipiFlow). Lower Confidence Limit is presented.

Adverse Events

Time Frame Adverse 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 Title Pretreatment iLux Ocular iLux Nonocular LipiFlow Ocular LipiFlow Nonocular
Arm/Group Description Events reported in this group occurred prior to exposure to the study treatment Events reported in this group occurred in eyes treated with the iLux device Events reported in this group occurred in subjects treated with the iLux device Events reported in this group occurred in eyes treated with the LipiFlow device Events reported in this group occurred in subjects treated with the LipiFlow device
All Cause Mortality
Pretreatment iLux Ocular iLux Nonocular LipiFlow Ocular LipiFlow Nonocular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/236 (0%) 0/238 (0%) 0/119 (0%) 0/234 (0%) 0/117 (0%)
Serious Adverse Events
Pretreatment iLux Ocular iLux Nonocular LipiFlow Ocular LipiFlow Nonocular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/236 (0%) 0/238 (0%) 3/119 (2.5%) 0/234 (0%) 1/117 (0.9%)
Gastrointestinal disorders
Pancreatitis 0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Infections and infestations
Cellulitis 0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Diverticulitis 0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Osteomyelitis 0/236 (0%) 0/238 (0%) 0/119 (0%) 0/234 (0%) 1/117 (0.9%)
Pelvic abscess 0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Investigations
White blood count increased 0/236 (0%) 0/238 (0%) 1/119 (0.8%) 0/234 (0%) 0/117 (0%)
Other (Not Including Serious) Adverse Events
Pretreatment iLux Ocular iLux Nonocular LipiFlow Ocular LipiFlow Nonocular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/236 (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/Title Sr. CDMA Project Lead, Ocular Health
Organization Alcon Research, LLC
Phone 1-888-451-3937
Email alcon.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