Clinical trial NCT03956225: Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Official title: Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Evaporative Dry Eye Disease
Keywords: Dry eye
MGD
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Alcon Investigator 9083
state: California
city: Los Angeles
country: United States
facility: Alcon Investigator 9081
state: California
city: San Diego
country: United States
facility: Alcon Investigator 9084
state: California
city: Panama City
country: United States
facility: Alcon Investigator 5127
state: Florida
city: Highland Park
country: United States
facility: Alcon Investigator 4782
state: Illinois
city: Pittsburg
country: United States
facility: Alcon Investigator 6567
state: Kansas
city: Louisville
country: United States
facility: Alcon Investigator 5582
state: Kentucky
city: Medina
country: United States
facility: Alcon Investigator 6402
state: Minnesota
city: Kansas City
country: United States
facility: Alcon Investigator 1455
state: Missouri
city: Poughkeepsie
country: United States
facility: Alcon Investigator 3828
state: New York
city: Granville
country: United States
facility: Alcon Investigator 8046
state: Ohio
city: Powell
country: United States
facility: Alcon Investigator 6313
state: Ohio
city: Chambersburg
country: United States
facility: Alcon Investigator 9082
state: Pennsylvania
city: Wichita Falls
country: United States
facility: Alcon Investigator 8028
state: Texas
city: Kirkland
country: United States
facility: Alcon Investigator 5163
state: Washington
Study officials:
affiliation: Alcon Research
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
citation: 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.