Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
NCT ID: NCT03956225
Last Updated: 2021-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
299 participants
INTERVENTIONAL
2019-06-25
2020-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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iLux
Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated.
Systane iLux® Dry Eye 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.
LipiFlow
Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated.
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.
Interventions
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Systane iLux® Dry Eye 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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* 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;
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Lead, Vision Care
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Alcon Investigator 9083
Long Beach, California, United States
Alcon Investigator 9081
Los Angeles, California, United States
Alcon Investigator 9084
San Diego, California, United States
Alcon Investigator 5127
Panama City, Florida, United States
Alcon Investigator 4782
Highland Park, Illinois, United States
Alcon Investigator 6567
Pittsburg, Kansas, United States
Alcon Investigator 5582
Louisville, Kentucky, United States
Alcon Investigator 6402
Medina, Minnesota, United States
Alcon Investigator 1455
Kansas City, Missouri, United States
Alcon Investigator 3828
Poughkeepsie, New York, United States
Alcon Investigator 8046
Granville, Ohio, United States
Alcon Investigator 6313
Powell, Ohio, United States
Alcon Investigator 9082
Chambersburg, Pennsylvania, United States
Alcon Investigator 8028
Wichita Falls, Texas, United States
Alcon Investigator 5163
Kirkland, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DEG723-P001
Identifier Type: -
Identifier Source: org_study_id
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