Trial Outcomes & Findings for Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study (NCT NCT03956225)

Last Updated: 2021-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

299 participants

Primary outcome timeframe

Baseline, Month 12

Results posted on

2021-10-08

Participant Flow

Subjects were recruited from 15 investigative sites located in the United States.

Of the 299 enrolled subjects, 63 were excluded prior to randomization as screen failures. This reporting group includes all randomized subjects/eyes (236/472).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	iLux Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.	LipiFlow Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.
Overall Study STARTED	119 238	117 234
Overall Study COMPLETED	114 228	113 226
Overall Study NOT COMPLETED	5 10	4 8

Reasons for withdrawal

Reasons for withdrawal
Measure	iLux Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.	LipiFlow Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.
Overall Study Lack of Efficacy	1	1
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	2	1
Overall Study Other Reasons	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iLux n=119 Participants Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.	LipiFlow n=117 Participants Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.	Total n=236 Participants Total of all reporting groups
Age, Continuous	58.4 years STANDARD_DEVIATION 13.4 • n=5 Participants	56.2 years STANDARD_DEVIATION 14.1 • n=7 Participants	57.3 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	86 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	31 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	114 Participants n=5 Participants	115 Participants n=7 Participants	229 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	103 Participants n=5 Participants	108 Participants n=7 Participants	211 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	119 participants n=5 Participants	117 participants n=7 Participants	236 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Full Analysis Set with data at visit

Outcome measures

Outcome measures
Measure	iLux n=226 eyes Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated.	LipiFlow n=226 eyes Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated.
Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12	17.4 score on a scale Standard Error 1.97	17.8 score on a scale Standard Error 1.98

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

iLux Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

iLux Nonocular

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

LipiFlow Ocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LipiFlow Nonocular

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=236 participants at risk Events reported in this group occurred prior to exposure to the study treatment	iLux Ocular n=238 participants at risk Events reported in this group occurred in eyes treated with the iLux device	iLux Nonocular n=119 participants at risk Events reported in this group occurred in subjects treated with the iLux device	LipiFlow Ocular n=234 participants at risk Events reported in this group occurred in eyes treated with the LipiFlow device	LipiFlow Nonocular n=117 participants at risk Events reported in this group occurred in subjects treated with the LipiFlow device
Gastrointestinal disorders Pancreatitis	0.00% 0/236 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/238 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.84% 1/119 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/234 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/117 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.
Infections and infestations Cellulitis	0.00% 0/236 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/238 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.84% 1/119 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/234 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/117 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.
Infections and infestations Diverticulitis	0.00% 0/236 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/238 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.84% 1/119 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/234 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/117 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.
Infections and infestations Osteomyelitis	0.00% 0/236 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/238 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/119 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/234 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.85% 1/117 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.
Infections and infestations Pelvic abscess	0.00% 0/236 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/238 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.84% 1/119 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/234 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/117 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.
Investigations White blood count increased	0.00% 0/236 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/238 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.84% 1/119 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/234 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.	0.00% 0/117 • Adverse events (AE's) were collected from time of consent to study exit, up to 12 months. 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.

Other adverse events

Adverse event data not reported

Additional Information

Sr. CDMA Project Lead, Ocular Health

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER