A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

Inclusion Criteria:

1. At least 18 years of age at the time of consent

2. Able to provide written voluntary informed consent

3. The same eye must satisfy the below inclusion criteria (a-e):

4. Subject-reported history of DED in at least 1 eye for at least 6 months priorto Visit 1

5. Tear-film break-up time ≤5 seconds at Visit 1

6. Total corneal fluorescein staining score ≥4 and ≤11 (ie, sum of inferior,superior, central, nasal, and temporal) according to the National Eye Institutescale at Visit 1

7. Total meibomian gland dysfunction score ≥3 (range, 0-15)

8. Unanesthetized Schirmer's test I score ≥5 mm

9. Ocular Surface Disease Index (OSDI) ≥25 at Visit 1

10. Able and willing to follow instructions, including participation in all trialassessments and visits.

Exclusion Criteria:

Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study

1. Had received Miebo as a prescription or as a study treatment in previous Mieboclinical studies

2. Have any clinically significant ocular surface slit lamp findings at Visit 1 and/or,in the opinion of the Investigator, have any findings that could interfere withtrial parameters, including:

3. History of eye trauma

4. History of Stevens-Johnson syndrome

5. Active blepharitis or lid margin inflammation

6. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid,or destruction of conjunctival goblet cells (as with vitamin A deficiency)

7. Abnormal lid anatomy causing incomplete eyelid closure

8. Abnormal cornea shape (keratoconus)

9. Corneal epithelial defect or significant confluent or filaments

10. History of herpetic keratitis

11. Pterygium

12. Ocular or periocular rosacea

13. Use of any of the following ocular therapies within 60 days prior to Visit 1:Vuity®, any topical ocular steroid treatments, prescription dry eye therapyincluding varenicline nasal spray, or topical anti-glaucoma medication

14. Had a LipiFlow® procedure, intense pulse light procedure, or any kind of otherprocedure affecting meibomian glands within 6 months prior to Visit 1

15. Had received or removed a permanent punctum plug within 3 months (6 months fordissolvable plugs) prior to Visit 1

16. Use of any eye drops (prescription or over-the counter, such as artificial tears orLumify®) and/or TrueTear™ device (intranasal tear neurostimulator) within 24 hoursprior to Visit 1

17. Have active ocular allergies or ocular allergies that are expected to be activeduring the trial period.

18. Have worn contact lenses within 1 month prior to Visit 1 or planned wear during thestudy.

19. Have undergone intraocular surgery or ocular laser surgery within 3 months prior toVisit 1; have undergone refractive surgery within 2 years prior to Visit 1

20. Have active ocular or systemic infection (bacterial, viral, or fungal), includingfever.

21. Female subjects who are pregnant, nursing, or planning a pregnancy

22. Female subjects of childbearing potential who are not using an acceptable means ofbirth control; acceptable methods of contraception include hormonal (oral,implantable, injectable, or transdermal) contraception; mechanical (spermicide inconjunction with a barrier such as a diaphragm or condom) contraception;intrauterine device; or surgical sterilization of partner. For non-sexually activefemale subjects, abstinence may be regarded as an adequate method of birth control;however, if the subject becomes sexually active during the trial, she must agree touse adequate birth control as defined above for the remainder of the trial.

23. Have an uncontrolled systemic disease that, in the opinion of the Investigator, willinterfere with the trial

24. Have a known allergy and/or sensitivity to the study treatment

25. Use of any oral medications known to cause ocular drying (eg, antihistamines,antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or isexpected to be unstable during the trial

26. Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6months prior to Visit 1

27. Have corrected visual acuity (VA) worse than or equal to +0.7 logarithm of theminimum angle of resolution (logMAR), as assessed with Snellen chart at Visit 1

28. Are currently enrolled in an investigational drug or device study or had used aninvestigational drug or device within 60 days prior to Visit 1.