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

Exclusion Criteria

• •1. Had received Miebo as a prescription or as a study treatment in previous Miebo clinical 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 with trial parameters, including:
• •1. History of eye trauma
• •2. History of Stevens-Johnson syndrome
• •3. Active blepharitis or lid margin inflammation
• •4. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
• •5. Abnormal lid anatomy causing incomplete eyelid closure
• •6. Abnormal cornea shape (keratoconus)
• •7. Corneal epithelial defect or significant confluent or filaments
• •8. History of herpetic keratitis
• •9. Pterygium
• •10. Ocular or periocular rosacea
• •3. Use of any of the following ocular therapies within 60 days prior to Visit 1: Vuity®, any topical ocular steroid treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication
• •4. Had a LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 1
• •5. Had received or removed a permanent punctum plug within 3 months (6 months for dissolvable plugs) prior to Visit 1
• •6. Use of any eye drops (prescription or over-the counter, such as artificial tears or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) within 24 hours prior to Visit 1
• •7. Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
• •8. Have worn contact lenses within 1 month prior to Visit 1 or planned wear during the study.
• •9. Have undergone intraocular surgery or ocular laser surgery within 3 months prior to Visit 1; have undergone refractive surgery within 2 years prior to Visit 1
• •10. Have active ocular or systemic infection (bacterial, viral, or fungal), including fever.
• •11. Female subjects who are pregnant, nursing, or planning a pregnancy
• •12. Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female 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 to use adequate birth control as defined above for the remainder of the trial.
• •13. Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
• •14. Have a known allergy and/or sensitivity to the study treatment
• •15. 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 is expected to be unstable during the trial
• •16. Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to Visit 1
• •17. Have corrected visual acuity (VA) worse than or equal to +0.7 logarithm of the minimum angle of resolution (logMAR), as assessed with Snellen chart at Visit 1
• •18. Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days prior to Visit 1.