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

Main Study (Stage1) Inclusion Criteria:

1. Age 22 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. Reports dry eye symptoms for three months prior to the study.

5. Ocular Surface Disease Index (OSDI) score between 23-79.

6. Tear break-up time (TBUT) <10 seconds in both eyes.

7. Agreement/ability to abstain from dry eye/MGD medications for the time between thetreatment visit/s and the final study visit. Ocular lubricants are allowed if nochanges are made during the study.

8. Reports having to use artificial tears or lubricants regulatory over the past monthto relieve dry eye symptoms.

9. Meibomian gland obstruction in both eyes based on a total Meibomian Gland SecretionScore ≤12 in each eye.

10. At least 15 glands in each lower eyelid should be expressible, with a sterile cottonswab, at the slit lamp.

Main Study (Stage1) Exclusion Criteria:

1. History of ocular surgery including intraocular, oculo-plastic, corneal orrefractive 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 3months of the baseline examination.

5. Active ocular herpes zoster or simplex of eye or eyelid or a history of these anytime.

6. Patient who are aphakic.

7. Cicatricial lid margin disease identified via slit lamp examination, includingpemphigoid, symblepharon, etc.

8. Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungalinfection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelidsincluding a hordeolum or stye).

9. Active ocular inflammation or history of chronic, recurrent ocular inflammationwithin 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., priorchemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 cornealfluorescein 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 eithereye.

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:

15. Systemic medication(s) that is known to cause ocular dryness (e.g.antihistamine, diuretics, anti-hypertensives, anti-depressants, hormonetherapy) whose dose of this medication(s) has not been stable within 30 daysprior to enrolment. There must be no anticipated adjustments to the dose ofthese medications for the duration of the trial;

16. Oral tetracyclines or azithromycin within 30 days prior to enrolment; or

17. Topical anti-glaucoma medications within 30 days prior to enrolment.

18. Any other systemic medication as per to the Investigator's discretion.

19. Women in childbearing age who are pregnant, nursing, or not utilizing adequate birthcontrol measures.

20. 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-steroidalanti-inflammatory drugs, corticosteroids) for at least 2 weeks and to maintainabstinence throughout the duration of the study (ocular lubricants are allowed if nochanges are made during the study).

21. Individuals wearing contact lenses 1 month prior study treatment (day 0), and at anypoint during the study.

22. Current skin cancer, malignant sites and/or advanced premalignant lesions or molesin the treatment area.

23. An impaired immune system condition or use of immunosuppressive medication.

24. Collagen disorders, keloid formation and/or abnormal wound healing.

25. Previous invasive/ablative procedures in the areas to be treated within 3 monthsprior to initial treatment or plans for such treatment during the course treatment,or before complete healing of such treatments has occurred.

26. Any patient who takes or has taken any oral or topical medications, such as but notlimited to topical retinoid (e.g., Retin-A), chemical peels, Latisse, Lash Boostwhich may cause fragile skin or impaired skin healing in the treatment area duringthe last 3 months and in the entire study period.

27. Any patient who has a history of bleeding coagulopathies.

28. Any patient who has tattoos or permanent makeup in the treated area.

29. Any patient who has burned, blistered, irritated, or sensitive skin in any of theareas to be treated.

30. Individuals using another ophthalmic investigational device or agent within 30 daysof study participation.

31. Any of the following dry eye treatments:

32. Office-based dry eye treatment (e.g. IPL, LipiFlow, iLux, TearCare, Tixel,etc.) within 12 months prior to enrolment;

33. Meibomian gland expression within 6 months prior to enrolment;

34. Blephex or debridement within 3 months prior to enrollment is an exclusion;

35. Punctal occlusion or punctal plug placement within 30 days prior to enrolment;

36. Use of iTear or TrueTear device within the past 2 weeks. (Subjects must refrainfrom using these devices for the duration of the study.); or

37. Any history of meibomian gland probing

38. Use of at-home warm compresses or lid hygiene products while participating in study.

39. IOP higher than 19 mmHg.

40. Use of Botulinum-Toxin in the last 6 months prior to the treatment in the treatmentarea.

41. Any co-existing condition, either ocular or non-ocular that, in the judgement of theinvestigator, could affect the safety or effectiveness of treatment or thecompliance of the subject to the protocol.

Study Extension (Stage 2)- Inclusion Criteria

• Subjects who have completed the main study CLN 0858 (stage 1) in the Tixel arm.

• TBUT -change from baseline in 1-month FU or 3-months FU was 2.5 seconds or above atleast in one eye in the main study.

• Provision of written informed consent for stage 2.

• Agreement/ability to abstain from dry eye/MGD medications for the time in theextension study. Ocular lubricants are allowed if no changes are made during thestudy.

Study Extension (Stage 2)-Exclusion Criteria

• Same as in the main study (stage 1).