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

NCT03055832 | Completed Results FDA Device

• 1 other identifier: 2020-03
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study was to compare changes in meibomian gland dysfunction (MGD), tear break-up time (TBT) and evaporative dry eye (EDE) symptoms after treatment with either the iLux® 2020 System or the LipiFlow® Thermal Pulsation System.

Conditions

Meibomian Gland Dysfunction

Keywords

iLux; LipiFlow; dry eye; Meibomian Gland Dysfunction; evaporative dry eye

Outcome Measures

Primary Outcomes (3)

• Change From Baseline to Week 4 in Meibomian Gland Score (MGS)

  Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.

  Baseline, Week 4

• Change From Baseline to Week 4 in Tear Break-Up Time (TBT)

  Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBT. A positive change value represents a lengthening in the tear break-up time and greater comfort.

  Baseline, Week 4

• Incidence (Number) of Device- or Procedure-related Adverse Events

  The number of device- or procedure-related adverse events was calculated, including changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion (eyelid rolled inward) or ectropion (eyelid sagging outward) or loss of lash integrity.

  Week 4

Secondary Outcomes (6)

• Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)

  Baseline, Week 4

• Mean Pain Score During Treatment

  Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment

• Mean Discomfort Score During Treatment

  Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment

• Change From Baseline to Post-Treatment in Ocular Surface Staining

  Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment

• Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)

  Baseline (Day 0), Immediately Post-Treatment (Day 0)

Study Arms (2)

iLux 2020 System

EXPERIMENTAL

Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual

Device: iLux 2020 System

LipiFlow Thermal Pulsation System

ACTIVE COMPARATOR

Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual

Device: LipiFlow Pulsation System

Interventions

iLux 2020 System DEVICE

Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands

iLux 2020 System

LipiFlow Pulsation System DEVICE

Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content

LipiFlow Thermal Pulsation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tear Film Innovations, Inc.: lead

Study Sites (7)

TearFilm Investigative Site

Phoenix, Arizona, 85016, United States

Location

TearFilm Investigative Site

Scottsdale, Arizona, 95260, United States

Location

TearFilm Investigative Site

San Diego, California, 92122, United States

Location

TearFilm Investigative Site

Centennial, Colorado, 80112, United States

Location

TearFilm Investigative Site

Greenwood Village, Colorado, 80111, United States

Location

TearFilm Investigative Site

Chesterfield, Missouri, 63017, United States

Location

TearFilm Investigative Site

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Rob Thornhill
• Organization: TearFilm Innovations, Inc.

rthornhill@tearfilm.com

844-458-9776

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Meibomian gland score will be assessed by a masked rater
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 16, 2017
• Study Start: February 9, 2017
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: April 12, 2023
• Results First Posted: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)