Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
1 other identifier
interventional
299
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Start
First participant enrolled
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2020
CompletedResults Posted
Study results publicly available
October 8, 2021
CompletedOctober 8, 2021
September 1, 2021
1.3 years
May 17, 2019
September 13, 2021
September 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
iLux
EXPERIMENTALSingle treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated.
LipiFlow
ACTIVE COMPARATORSingle treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (15)
Alcon Investigator 9083
Long Beach, California, 90815, United States
Alcon Investigator 9081
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
Related Publications (1)
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.
PMID: 35383732DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. CDMA Project Lead, Ocular Health
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Vision Care
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 20, 2019
Study Start
June 25, 2019
Primary Completion
October 24, 2020
Study Completion
October 24, 2020
Last Updated
October 8, 2021
Results First Posted
October 8, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share