to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction

Exclusion Criteria

• •1. History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 6 months.
• •2. Patient with giant papillary conjunctivitis.
• •3. Patient with punctal plugs or who have had punctal cautery.
• •4. Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
• •5. Active ocular herpes zoster or simplex of eye or eyelid or a history of these any time.
• •6. Patient who are aphakic.
• •7. Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
• •8. 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).
• •9. 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).
• •10. 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).
• •11. Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye.
• •12. Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4).
• •13. 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).
• •14. Use of any of the following medications:
• •1. Systemic medication(s) that is known to cause ocular dryness (e.g. antihistamine, diuretics, anti-hypertensives, anti-depressants, hormone therapy) whose dose of this medication(s) has not been stable within 30 days prior to enrolment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
• •2. Oral tetracyclines or azithromycin within 30 days prior to enrolment; or
• •3. Topical anti-glaucoma medications within 30 days prior to enrolment.
• •4. Any other systemic medication as per to the Investigator's discretion.
• •15. Women in childbearing age who are pregnant, nursing, or not utilizing adequate birth control measures.
• •16. Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution (Xiidra) within 45 days prior to study treatment (day 0), or any other dry eye or MGD medications (antibiotics, non-steroidal anti-inflammatory drugs, corticosteroids) for at least 2 weeks and to maintain abstinence throughout the duration of the study (ocular lubricants are allowed if no changes are made during the study).
• •17. Individuals wearing contact lenses 1 month prior study treatment (day 0), and at any point during the study.
• •18. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
• •19. An impaired immune system condition or use of immunosuppressive medication.
• •20. Collagen disorders, keloid formation and/or abnormal wound healing.
• •21. Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course treatment, or before complete healing of such treatments has occurred.
• •22. Any patient who takes or has taken any oral or topical medications, such as but not limited to topical retinoid (e.g., Retin-A), chemical peels, Latisse, Lash Boost which may cause fragile skin or impaired skin healing in the treatment area during the last 3 months and in the entire study period.
• •23. Any patient who has a history of bleeding coagulopathies.
• •24. Any patient who has tattoos or permanent makeup in the treated area.
• •25. Any patient who has burned, blistered, irritated, or sensitive skin in any of the areas to be treated.
• •26. Individuals using another ophthalmic investigational device or agent within 30 days of study participation.
• •27. Any of the following dry eye treatments:
• •1. Office-based dry eye treatment (e.g. IPL, LipiFlow, iLux, TearCare, Tixel, etc.) within 12 months prior to enrolment;
• •2. Meibomian gland expression within 6 months prior to enrolment;
• •3. Blephex or debridement within 3 months prior to enrollment is an exclusion;
• •4. Punctal occlusion or punctal plug placement within 30 days prior to enrolment;
• •5. Use of iTear or TrueTear device within the past 2 weeks. (Subjects must refrain from using these devices for the duration of the study.); or
• •6. Any history of meibomian gland probing
• •28. Use of at-home warm compresses or lid hygiene products while participating in study.
• •29. IOP higher than 19 mmHg.
• •30. Use of Botulinum-Toxin in the last 6 months prior to the treatment in the treatment area.
• •31. Any co-existing condition, either ocular or non-ocular that, in the judgement of the investigator, could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol.
• •\* Same as in the main study (stage 1).