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

The primary objective of this study is to evaluate early outcomes with Miebo treatment in subjects with Dry Eye Disease (DED)

Inclusion criteria

• At least 18 years of age at the time of consent
• Able to provide written voluntary informed consent
• The same eye must satisfy the below inclusion criteria (a-e):

• Subject-reported history of DED in at least 1 eye for at least 6 months prior to Visit 1
• Tear-film break-up time ≤5 seconds at Visit 1
• Total corneal fluorescein staining score ≥4 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute scale at Visit 1
• Total meibomian gland dysfunction score ≥3 (range, 0-15)
• Unanesthetized Schirmer's test I score ≥5 mm
• Ocular Surface Disease Index (OSDI) ≥25 at Visit 1
• Able and willing to follow instructions, including participation in all trial assessments 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

• Had received Miebo as a prescription or as a study treatment in previous Miebo clinical studies
• 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:

• History of eye trauma
• History of Stevens-Johnson syndrome
• Active blepharitis or lid margin inflammation
• DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
• Abnormal lid anatomy causing incomplete eyelid closure
• Abnormal cornea shape (keratoconus)
• Corneal epithelial defect or significant confluent or filaments
• History of herpetic keratitis
• Pterygium
• Ocular or periocular rosacea
• 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
• Had a LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 1
• Had received or removed a permanent punctum plug within 3 months (6 months for dissolvable plugs) prior to Visit 1
• 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
• Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
• Have worn contact lenses within 1 month prior to Visit 1 or planned wear during the study.
• 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
• Have active ocular or systemic infection (bacterial, viral, or fungal), including fever.
• Female subjects who are pregnant, nursing, or planning a pregnancy
• 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.
• Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
• Have a known allergy and/or sensitivity to the study treatment
• 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
• Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to Visit 1
• 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
• 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.