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Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03055832
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tear Film Innovations, Inc.

Brief Summary:
Determine the safety and effectiveness of the iLux System in adults with meibomian gland dysfunction (MGD)

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Device: iLux 2020 System Device: LipiFlow Pulsation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Meibomian gland score will be assessed by a masked rater
Primary Purpose: Treatment
Official Title: Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Actual Study Start Date : February 9, 2017
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : July 20, 2017

Arm Intervention/treatment
Experimental: iLux 2020 System
Meibomian Gland Treatment
Device: iLux 2020 System
Heating and compression to express clogged meibomian glands

Active Comparator: LipiFlow Thermal Pulsation System
Meibomian Gland Treatment
Device: LipiFlow Pulsation System
Heating and compression to express clogged meibomian glands




Primary Outcome Measures :
  1. Meibomian Gland Score (MGS) [ Time Frame: 4 weeks ]
    Change from baseline to the 4-week exam

  2. Tear Break-Up Time (TBT) [ Time Frame: 4 weeks ]
    Change from baseline to the 4-week exam

  3. Incidence of device-related adverse events [ Time Frame: 4 weeks ]
    Incidence of changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion or ectropion or loss of lash integrity


Secondary Outcome Measures :
  1. Ocular Surface Disease Index (OSDI) [ Time Frame: 4 weeks ]
    Change from baseline in subject symptoms

  2. Incidence of changes in pain [ Time Frame: 4 weeks ]
  3. Incidence of changes in discomfort [ Time Frame: 4 weeks ]
    Change from baseline

  4. Incidence of changes in ocular surface staining [ Time Frame: 4 weeks ]
    Change from baseline

  5. Incidence of changes in intraocular pressure [ Time Frame: 4 weeks ]
    Change from baseline

  6. Incidence of changes in BSCVA [ Time Frame: 4 weeks ]
    Change from baseline



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:

  • Age 18 years and older of any gender or race
  • Written informed consent to participate in the study
  • Willingness and ability to return for all study visits
  • Positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit
  • Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure
  • Tear break-up time <10 seconds
  • Agreement/ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (ocular lubricants are allowed if no changes are made during the study)

Exclusion Criteria:

  • History of ocular or corneal surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
  • Subjects with giant papillary conjunctivitis
  • Subject with punctal plugs or who have had punctal cautery
  • Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination
  • Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months
  • Subjects who are aphakic
  • Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
  • Active ocular infection
  • Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
  • Ocular surface abnormality that may compromise corneal integrity
  • Lid surface abnormalities that affect lid function in either eye
  • Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
  • Systemic disease conditions that cause dry eye
  • Unwillingness to abstain from systemic medications known to cause dryness for the study duration
  • Women who are pregnant, nursing, or not utilizing adequate birth control measures
  • Individuals who have either changed the dosing of systemic medications or non-dry eye/MGD ophthalmic medications within the past 30 days prior to screening
  • Individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study
  • Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution 5% (Xiidra) within 3 months, or any other dry eye or MGD medications within 2 weeks of screening (ocular lubricants are allowed if no changes are made during the study)
  • Individuals wearing contact lenses at any time during the prior three months or during the study period
  • Eyelid tattoos, including permanent eyeliner makeup
  • Individuals that were treated with LipiFlow in either eye in the last 24 months
  • Individuals using another ophthalmic investigational device or agent within 30 days of study participation
  • Individuals who are unable to complete the required patient questionnaires in English

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): NCT03055832


Locations
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United States, Arizona
Barnett-Dulaney-Perkins Eye Center
Phoenix, Arizona, United States, 85016
Scwartz Laser Eye Center
Scottsdale, Arizona, United States, 95260
United States, California
Gordon Schanzlin
San Diego, California, United States, 92122
United States, Colorado
Eye Care Consultants-Vision Source
Centennial, Colorado, United States, 80112
Dishler Laser Institute
Greenwood Village, Colorado, United States, 80111
United States, Missouri
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Tear Film Innovations, Inc.

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Responsible Party: Tear Film Innovations, Inc.
ClinicalTrials.gov Identifier: NCT03055832     History of Changes
Other Study ID Numbers: 2020-03
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
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: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No