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

Primary Purpose

Meibomian Gland Dysfunction, Evaporative Dry Eye Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systane iLux® Dry Eye System
LipiFlow® Thermal Pulsation System
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Dry eye, MGD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigator 9083
  • Alcon Investigator 9081
  • Alcon Investigator 9084
  • Alcon Investigator 5127
  • Alcon Investigator 4782
  • Alcon Investigator 6567
  • Alcon Investigator 5582
  • Alcon Investigator 6402
  • Alcon Investigator 1455
  • Alcon Investigator 3828
  • Alcon Investigator 8046
  • Alcon Investigator 6313
  • Alcon Investigator 9082
  • Alcon Investigator 8028
  • Alcon Investigator 5163

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iLux

LipiFlow

Arm Description

Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated.

Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2019
Last Updated
September 13, 2021
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03956225
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
October 24, 2020 (Actual)
Study Completion Date
October 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Evaporative Dry Eye Disease
Keywords
Dry eye, MGD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iLux
Arm Type
Experimental
Arm Description
Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated.
Arm Title
LipiFlow
Arm Type
Active Comparator
Arm Description
Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated.
Intervention Type
Device
Intervention Name(s)
Systane iLux® Dry Eye System
Intervention Description
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
Intervention Type
Device
Intervention Name(s)
LipiFlow® Thermal Pulsation System
Intervention Description
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 Measure Information:
Title
Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
Description
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.
Time Frame
Baseline, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Vision Care
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 9083
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Facility Name
Alcon Investigator 9081
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Alcon Investigator 9084
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Alcon Investigator 5127
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Alcon Investigator 4782
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Alcon Investigator 6567
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Alcon Investigator 5582
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Alcon Investigator 6402
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Alcon Investigator 1455
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Alcon Investigator 3828
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Alcon Investigator 8046
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Alcon Investigator 6313
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigator 9082
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Alcon Investigator 8028
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76308
Country
United States
Facility Name
Alcon Investigator 5163
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35383732
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.
Results Reference
derived

Learn more about this trial

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

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