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Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study

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ClinicalTrials.gov Identifier: NCT03956225
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to demonstrate that iLux MGD treatment is comparable to LipiFlow MGD treatment at 12 months post single treatment.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Evaporative Dry Eye Disease Device: iLux® system Device: LipiFlow® Thermal Pulsation System Not Applicable

Detailed Description:
Subjects will be expected to attend a total of 8 visits (Screening/Baseline, Treatment, 2-Week Follow-up, 1-Month Follow-up, 3-Month Follow-up, 6-Month Follow-up, 9-Month Follow-up and 12-Month Follow-up/Exit).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : November 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: iLux
Single treatment with 12-month follow up
Device: iLux® 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.

Active Comparator: LipiFlow
Single treatment with 12-month follow up
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.




Primary Outcome Measures :
  1. Mean change from baseline in Meibomian Gland Score (MGS) at Month 12 [ Time Frame: Baseline, Month 12 ]
    Meibomian glands on the eyelids will be assessed by the examiner using a Meibomian Gland Evaluator using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) will be evaluated and scored, from 0-3 for a maximum MGS of 45 in each eye. MGS scoring is as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign an Informed Consent;
  • 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

  • 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 inclusion and exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956225


Contacts
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Contact: Alcon Call Center 888-451-3937 alcon.medinfo@alcon.com

Locations
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United States, Minnesota
Alcon Investigative Site Recruiting
Medina, Minnesota, United States, 55340
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Study Director Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03956225     History of Changes
Other Study ID Numbers: DEG723-P001
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Alcon Research:
Meibomian Gland Dysfunction
Evaporative Dry Eye Disease

Additional relevant MeSH terms:
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Eye Diseases