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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iLux | Experimental | Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated. |
|
| LipiFlow | Active Comparator | Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane iLux® Dry Eye System | Device | Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 12 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 9083 | Long Beach | California | 90815 | United States | ||
| Alcon Investigator 9081 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35383732 | Derived | Wesley G, Bickle K, Downing J, Fisher B, Greene B, Heinrich C, Kading D, Kannarr S, Miller J, Modi S, Ludwick D, Tauber J, Srinivasan S, Manoj V. Comparison of Two Thermal Pulsation Systems in the Treatment of Meibomian Gland Dysfunction: A Randomized, Multicenter Study. Optom Vis Sci. 2022 Apr 1;99(4):323-332. doi: 10.1097/OPX.0000000000001892. |
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Of the 299 enrolled subjects, 63 were excluded prior to randomization as screen failures. This reporting group includes all randomized subjects/eyes (236/472).
Subjects were recruited from 15 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | iLux | Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated. |
| FG001 | LipiFlow | Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2019 | Aug 24, 2021 |
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| LipiFlow® Thermal Pulsation System | Device | Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids. |
|
| Los Angeles |
| California |
| 90013 |
| United States |
| Alcon Investigator 9084 | San Diego | California | 92122 | United States |
| Alcon Investigator 5127 | Panama City | Florida | 32405 | United States |
| Alcon Investigator 4782 | Highland Park | Illinois | 60035 | United States |
| Alcon Investigator 6567 | Pittsburg | Kansas | 66762 | United States |
| Alcon Investigator 5582 | Louisville | Kentucky | 40206 | United States |
| Alcon Investigator 6402 | Medina | Minnesota | 55340 | United States |
| Alcon Investigator 1455 | Kansas City | Missouri | 64111 | United States |
| Alcon Investigator 3828 | Poughkeepsie | New York | 12603 | United States |
| Alcon Investigator 8046 | Granville | Ohio | 43023 | United States |
| Alcon Investigator 6313 | Powell | Ohio | 43065 | United States |
| Alcon Investigator 9082 | Chambersburg | Pennsylvania | 17201 | United States |
| Alcon Investigator 8028 | Wichita Falls | Texas | 76308 | United States |
| Alcon Investigator 5163 | Kirkland | Washington | 98034 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set (FAS): All randomized subjects exposed to any study treatment evaluated in this study
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| ID | Title | Description |
|---|---|---|
| BG000 | iLux | Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes were treated. |
| BG001 | LipiFlow | Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes were treated. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set with data at visit | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 12 | eyes | eyes |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | Events reported in this group occurred prior to exposure to the study treatment | 0 | 236 | 0 | 236 | 0 | 236 |
| EG001 | iLux Ocular | Events reported in this group occurred in eyes treated with the iLux device | 0 | 238 | 0 | 238 | 0 | 238 |
| EG002 | iLux Nonocular | Events reported in this group occurred in subjects treated with the iLux device | 0 | 119 | 3 | 119 | 0 | 119 |
| EG003 | LipiFlow Ocular | Events reported in this group occurred in eyes treated with the LipiFlow device | 0 | 234 | 0 | 234 | 0 | 234 |
| EG004 | LipiFlow Nonocular | Events reported in this group occurred in subjects treated with the LipiFlow device | 0 | 117 | 1 | 117 | 0 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. CDMA Project Lead, Ocular Health | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2020 | Aug 24, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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