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

Overview

An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

Description

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

Eligibility

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):
   1. Subject-reported history of DED in at least 1 eye for at least 6 months prior to Visit 1
   2. Tear-film break-up time ≤5 seconds at Visit 1
   3. 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
   4. Total meibomian gland dysfunction score ≥3 (range, 0-15)
   5. Unanesthetized Schirmer's test I score ≥5 mm
4. Ocular Surface Disease Index (OSDI) ≥25 at Visit 1
5. 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
          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.