Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
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 |
---|---|---|
|
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
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
- 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
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.- DEG723-P001
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
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
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 |
alcon.medinfo@alcon.com |
- DEG723-P001