An interventional study of Systane iLux® Dry Eye System and LipiFlow® Thermal Pulsation System in Meibomian Gland Dysfunction and Evaporative Dry Eye Disease, sponsored by Alcon Research. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
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.
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 299 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
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Exclusion Criteria
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
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.
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
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.
Time frame: Baseline, Month 12
Subjects were recruited from 15 investigative sites located in the United States.
| Milestone | iLux | LipiFlow |
|---|---|---|
| Started | 119 | 117 |
| Completed | 114 | 113 |
| Not completed | 5 | 4 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Other reasons | 2 | 1 |
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.
| score on a scale | iLux | LipiFlow |
|---|---|---|
| Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 | 17.4 ± 1.97 | 17.8 ± 1.98 |
Collected over Adverse events (AE's) were collected from time of consent to study exit, up to 12 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/236 (0%) | 0/236 (0%) | 0/236 (0%) |
| iLux Ocular | 0/238 (0%) | 0/238 (0%) | 0/238 (0%) |
| iLux Nonocular | 0/119 (0%) | 3/119 (2.5%) | 0/119 (0%) |
| LipiFlow Ocular | 0/234 (0%) | 0/234 (0%) | 0/234 (0%) |
| LipiFlow Nonocular | 0/117 (0%) | 1/117 (0.9%) | 0/117 (0%) |
| Event | Pretreatment | iLux Ocular | iLux Nonocular | LipiFlow Ocular | LipiFlow Nonocular |
|---|---|---|---|---|---|
| OsteomyelitisInfections and infestations | 0/236 | 0/238 | 0/119 | 0/234 | 1/117 |
| PancreatitisGastrointestinal disorders | 0/236 | 0/238 | 1/119 | 0/234 | 0/117 |
| CellulitisInfections and infestations | 0/236 | 0/238 | 1/119 | 0/234 | 0/117 |
| DiverticulitisInfections and infestations | 0/236 | 0/238 | 1/119 | 0/234 | 0/117 |
| Pelvic abscessInfections and infestations | 0/236 | 0/238 | 1/119 | 0/234 | 0/117 |
| White blood count increasedInvestigations | 0/236 | 0/238 | 1/119 | 0/234 | 0/117 |
Full Analysis Set (FAS): All randomized subjects exposed to any study treatment evaluated in this study
| Age, Continuous(years) | iLux | LipiFlow | Total |
|---|---|---|---|
| Mean | 58.4 ± 13.4 | 56.2 ± 14.1 | 57.3 ± 13.8 |
| Sex: Female, Male(Participants) | iLux | LipiFlow | Total |
|---|---|---|---|
| Female | 94 | 86 | 180 |
| Male | 25 | 31 | 56 |
| Ethnicity (NIH/OMB)(Participants) | iLux | LipiFlow | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 7 |
| Not Hispanic or Latino | 114 | 115 | 229 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | iLux | LipiFlow | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 5 | 13 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 6 | 4 | 10 |
| White | 103 | 108 | 211 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | iLux | LipiFlow | Total |
|---|---|---|---|
| United States | 119 | 117 | 236 |
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