Clinical trial NCT03055832: Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Official title: Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Keywords: iLux
LipiFlow
dry eye
Meibomian Gland Dysfunction
evaporative dry eye
Lead sponsor: Tear Film Innovations, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: At the Baseline visit (Day 0), subjects were assessed pre-treatment, during treatment, and post-treatment.

Eligibility 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

Primary outcomes:
measure: Change From Baseline to Week 4 in Meibomian Gland Score (MGS)
timeFrame: Baseline, Week 4
measure: Change From Baseline to Week 4 in Tear Break-Up Time (TBT)
timeFrame: Baseline, Week 4
measure: Incidence (Number) of Device- or Procedure-related Adverse Events
timeFrame: Week 4
Secondary outcomes:
measure: Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)
timeFrame: Baseline, Week 4
measure: Mean Pain Score During Treatment
timeFrame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
measure: Mean Discomfort Score During Treatment
timeFrame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
measure: Change From Baseline to Post-Treatment in Ocular Surface Staining
timeFrame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
measure: Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)
timeFrame: Baseline (Day 0), Immediately Post-Treatment (Day 0)
measure: Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)
timeFrame: Baseline (Day 0), Immediately Post-Treatment (Day 0)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: TearFilm Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: TearFilm Investigative Site
state: Arizona
city: San Diego
country: United States
facility: TearFilm Investigative Site
state: California
city: Centennial
country: United States
facility: TearFilm Investigative Site
state: Colorado
city: Greenwood Village
country: United States
facility: TearFilm Investigative Site
state: Colorado
city: Chesterfield
country: United States
facility: TearFilm Investigative Site
state: Missouri
city: Kansas City
country: United States
facility: TearFilm Investigative Site
state: Missouri
Study officials:
References: