| Eligibility |
Inclusion Criteria:
- At Visit 1, individuals of any gender or any race will be eligible for study
participation if they:
1. Have provided written informed consent prior to any study procedures.
2. Are 18 years of age or above.
3. Have a clinical diagnosis of moderate to severe MGD and who meet the following
criteria, in a qualifying eyelid, at both Visit 1 (Screening) and Visit 2
(Randomization) examinations:
1. Clinical sign severity score of at least 2 (moderate) on vascular
engorgement at the eyelid margin and
2. Clinical sign severity score of at least 2 (moderate) on plugging of the
meibomian glands.
3. Eye Discomfort Symptom score of = 40 using VAS (0-100 point scale)
4. Meet the following criteria, in a qualifying eye (same eye that qualifies for
Inclusion #3), at both the Visit 1 (Screening) and Visit 2 (Randomization)
examinations:
1. Fluorescein corneal staining (FCS) total score = 3 in the inferior, central,
and nasal region combined score (NEI/Industry Workshop sections 1, 4 and 5
with 0-9 scale)
2. Schirmer score of >7 mm without topical anesthesia
5. Are willing and able to follow instructions and can be present for the required
study visits for the duration of the study.
6. Have a BCVA, using corrective lenses if necessary, in both eyes of at least +0.7
as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) or modified
ETDRS.
7. If female, are non-pregnant, non-lactating and women of childbearing potential
(WOCBP) must be using an acceptable method of birth control [e.g., an
Intrauterine Contraceptive Device (IUCD) with a failure rate of <1%, hormonal
contraceptives, or a barrier method] for the duration of the study. If a female
subject is currently abstinent, they must agree to use one of the acceptable
methods of birth control before they become sexually active.
Exclusion Criteria:
In order for subjects to be eligible at Visit 1 they may not:
1. Have presence of inflammation and/or active structural change in the iris or anterior
chamber.
2. Have lid structural abnormalities such as entropion or ectropion.
3. In the eyelid that qualifies (based on Inclusion #3), have grade level 4 (Obstructed)
on Character of Secretion of Meibomian Glands or grade level 4 (No glands are
expressible) on the Expressibility of Meibomian Glands.
4. Subjects with ocular inflammatory conditions (e.g., conjunctivitis, keratitis,
anterior blepharitis, etc.) not related to MGD.
5. Subjects who have FCS total score = 15 or a score = 3, in either eye, in the superior
region NEI/Industry Workshop scale or subjects who have FCS with diffuse confluent
staining, filaments or frank epithelial defects.
6. Have suspected ocular fungal, viral or bacterial infection.
7. Have had penetrating intraocular surgery in the past 90 days or require penetrating
intraocular surgery during the study.
8. Have had ocular surface surgery within 12 months of Visit 1 (e.g., LASIK, refractive,
pterygium removal).
9. Subjects who within the past 90 days have had cauterization of the punctum or changes
to the status (insertion or removal) of punctal plug(s) before the Screening Visit.
10. Have used topical ocular or oral antibiotics within 30 days of the study or expect to
use during the study.
11. Have used LipiFlow or hypochlorous acid spray within 30 days of the study or expect to
use during the study.
12. If using inhaled or intranasal corticosteroids, unable to maintain a stable dose for
the duration of the study.
13. Have ever used isotretinoin.
14. If using Omega-3 supplements, dose must be stable for 3 months prior to Visit 1 and
for the duration of the study.
15. Have used topical cyclosporine within 30 days of the study or during the study.
16. Have used topical lifitegrast within 30 days of the study or during the study.
17. Have used systemic corticosteroids within 30 days prior to study entry or during study
participation.
18. Have used topical ocular corticosteroids or ocular non-steroidal anti-inflammatory
drugs (NSAIDs) within 30 days prior to study entry and during study participation.
19. Have used topical ocular antihistamine and/or mast cell stabilizers within 30 days
prior to study entry or during study participation.
20. Are unable or unwilling to discontinue using any preserved or unpreserved topical
ocular medications (including artificial tears) upon Screening and for the duration of
the study.
21. Are unwilling to discontinue use of contact lenses during the study.
22. Are unwilling to discontinue use of cosmetic makeup applied to the eyelids or eye
lashes at the Screening Visit and during the study. If makeup was used, it should be
removed at least 12 hours prior to Visit 1.
23. Have a known hypersensitivity to minocycline, any other tetracycline antibiotic, or to
any of the other ingredients in the investigational product.
24. Are unable or unwilling to withhold the use of eyelid scrubs or use of mechanical
therapy during the study.
25. Have been diagnosed with glaucoma or are currently using any glaucoma medication.
26. Have a history of herpetic keratitis.
27. Have a concomitant ocular pathology other than condition under study assessed as
potentially confounding by the investigator.
28. Have a serious systemic disease or uncontrolled medical condition that in the judgment
of the investigator could confound study assessments or limit compliance.
29. Have been exposed to any investigational drug or investigational device within the
preceding 30 days.
30. Are an employee of the site that is directly involved in the management,
administration, or support of this study or be an immediate family member of the same.
31. Have trigger factors including conjunctivochalasis, allergic conjunctivitis, contact
lens intolerance, trichiasis, epithelial basement membrane dystrophy, infectious
keratitis or conjunctivitis.
32. Have a documented history of ocular allergies, which, in the judgment of the
investigator, are likely to have an acute increase in severity due to the expected
timing of the exposure to the allergen to which the subject is sensitive. Subjects
sensitive to seasonal allergens that are not expected to be present during the study
are permitted.
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