iLux Treatment for Meibomian Gland Dysfunction (MGD)
1 other identifier
interventional
30
1 country
3
Brief Summary
The purpose of this study is to assess changes in meibomian gland function and evaporative dry eye symptoms after treatment with the iLux medical device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2015
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2016
CompletedFirst Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedResults Posted
Study results publicly available
November 12, 2020
CompletedNovember 12, 2020
October 1, 2020
2 months
February 10, 2017
October 7, 2020
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator (MGE 1000) device while viewing the eyelid margin with a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3, for a resultant overall score of 0-45 for 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. Eyes were assessed individually.
Baseline (Day 0 pretreatment), Week 1, Month 1
Change From Baseline in Tear Break-Up Time (TBUT)
The investigator instilled a drop of fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.
Baseline (Day 0 pretreatment), Week 1, Month 1
Secondary Outcomes (2)
Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score
Baseline (Day 0 pretreatment), Week 1, Month 1
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
Baseline (Day 0 pretreatment), Month 1
Study Arms (1)
iLux 2020 System
EXPERIMENTALMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Interventions
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
Eligibility Criteria
You may qualify if:
- Age 18 years and older of any gender or race
- Provision of written informed consent prior to study participation
- Willingness and ability to return for all study visits
- A positive history of self-reported dry eye symptoms for three months prior to the study using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and a score of \> 6.
- Need for regular use of artificial tears, lubricants, or rewetting drops in both eyes
- Evidence of meibomian gland (MG) obstruction, based on a total meibomian gland secretion score of \< 12 out of a maximum score of 45, for 15 glands (5 nasal, 5 medial, 5 temporal) of the lower eyelid of each eye. Glands expressed \& graded from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid).
You may not qualify if:
- History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
- Ocular trauma or herpetic keratitis within the previous 3 months
- Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
- Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)
- Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g. retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
- Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy
- Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye
- Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
- Ocular trauma, chemical burns, or limbal stem cell deficiency
- Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome)
- Women who are pregnant, nursing, or not utilizing adequate birth control measures
- Individuals who have either changed the dosing of systemic or ophthalmic medication within the past 30 days prior to screening or 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) within 2 months, or topical medications other than non-preserved artificial tears within 2 weeks.
- Individuals using another investigational device or agent within 30 days of study participation
- Contact lens wearers or individuals who have worn contact lenses in the last 30 days or anticipate wearing contact lenses during this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
TearFilm Investigative Site
Encinitas, California, 92924, United States
TearFilm Investigative Site
San Diego, California, 92122, United States
TearFilm Investigative Site
San Diego, California, 92128, United States
Related Publications (1)
Schanzlin D, Owen JP, Klein S, Yeh TN, Merchea MM, Bullimore MA. Efficacy of the Systane iLux Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction After 1 Week and 1 Month: A Prospective Study. Eye Contact Lens. 2022 Apr 1;48(4):155-161. doi: 10.1097/ICL.0000000000000847.
PMID: 34620785DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior CDMA Project Lead, CDMA Ocular Health
- Organization
- Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 16, 2017
Study Start
December 7, 2015
Primary Completion
February 18, 2016
Study Completion
February 18, 2016
Last Updated
November 12, 2020
Results First Posted
November 12, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share