Clinical trial NCT03055650: iLux Treatment for Meibomian Gland Dysfunction (MGD)
Official title: iLux Treatment for Meibomian Gland Dysfunction (MGD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaporative Dry Eye
Keywords: Evaporative Dry Eye (EDE)
Meibomian Gland Dysfunction (MGD)
Lead sponsor: Tear Film Innovations, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and older of any gender or race
2. Provision of written informed consent prior to study participation
3. Willingness and ability to return for all study visits
4. 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.
5. Need for regular use of artificial tears, lubricants, or rewetting drops in both eyes
6. 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).

Exclusion Criteria:

1. History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
2. Ocular trauma or herpetic keratitis within the previous 3 months
3. Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
4. 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)
5. 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)
6. 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
7. Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye
8. Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
9. Ocular trauma, chemical burns, or limbal stem cell deficiency
10. 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)
11. Women who are pregnant, nursing, or not utilizing adequate birth control measures
12. 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
13. 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.
14. Individuals using another investigational device or agent within 30 days of study participation
15. Contact lens wearers or individuals who have worn contact lenses in the last 30 days or anticipate wearing contact lenses during this study.

Primary outcomes:
measure: Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
timeFrame: Baseline (Day 0 pretreatment), Week 1, Month 1
measure: Change From Baseline in Tear Break-Up Time (TBUT)
timeFrame: Baseline (Day 0 pretreatment), Week 1, Month 1
Secondary outcomes:
measure: Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score
timeFrame: Baseline (Day 0 pretreatment), Week 1, Month 1
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
timeFrame: Baseline (Day 0 pretreatment), Month 1
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: TearFilm Investigative Site
state: California
city: San Diego
country: United States
facility: TearFilm Investigative Site
state: California
city: San Diego
country: United States
facility: TearFilm Investigative Site
state: California
Study officials:
References:
citation: 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.