Clinical trial: iLux Treatment for Meibomian Gland Dysfunction (MGD) (NCT03055650)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? 0