Phase
Condition
N/ATreatment
Miebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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):
At least 1 eye with a visually significant cataract that has been scheduled forcataract surgery (eligible eye can be a subject's second eye to undergocataract surgery as long as all eligibility criteria are met in that eye)
Candidate for routine, uncomplicated cataract surgery (phacoemulsification withposterior chamber intraocular lens [IOL] implantation, not combined with anyother surgery)
In the Investigator's opinion, subject has potential postoperative pinholeSnellen visual acuity of at least 20/200 in both eyes
Tear film break-up time ≤10 sec at Visit 1
Total CFS score ≥2 and ≤11 (ie, sum of inferior, superior, central, nasal, andtemporal), using the National Eye Institute scale at Visit 1
Ocular Surface Disease Index (OSDI) ≥23 at Visit 1
Able and willing to follow instructions, including participation in all trialassessments and visits.
Exclusion
Exclusion Criteria:
Have any clinically significant ocular surface slit-lamp findings in the study eyeand/or, in the opinion of the Investigator, have any findings that could interferewith 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 staining or filaments
History of herpetic keratitis
Ocular or periocular rosacea
Pterygium in either eye
Use of any of the following ocular therapies in the study eye within 30 days priorto Visit 1: Vuity®, Qlosi™, topical ocular steroid treatments, prescription dry eyetherapy including varenicline nasal spray, or topical anti-glaucoma medication
Had a LipiFlow® procedure, intense pulse light procedure, or any kind of otherprocedure affecting meibomian glands in the study eye within 3 months prior to Visit 1
Had received or removed a permanent punctum plug in the study eye within 1 month (3months for dissolvable punctum plugs) prior to Visit 1
Use of any eye drops (prescription or over-the-counter, such as artificial tears orLumify®) and/orTrueTear™ device (intranasal tear neurostimulator) in the study eyewithin 24 hours prior to Visit 1
Have active ocular allergies or ocular allergies that are expected to be activeduring the trial period
Have worn contact lenses within 1 month prior to Visit 1 or planned wear during thestudy
Have undergone intraocular surgery or ocular laser surgery in the study eye within 3months prior to Visit 1; have undergone refractive surgery in the study eye within 2years prior to Visit 1
Have active ocular or systemic infection (bacterial, viral, or fungal), includingfever
Female subjects who are pregnant, nursing, or planning a pregnancy
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.
Have an uncontrolled systemic disease that, in the opinion of the Investigator, willinterfere with the trial
Have a known allergy and/or sensitivity to the investigational drug
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
Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6months prior to Visit 1
Are currently enrolled in an investigational drug or device study or had used aninvestigational drug or device within 60 days prior to Visit 1.
Study Design
Study Description
Connect with a study center
Site 105
Laguna Hills, California 92655
United StatesSite Not Available
Site 102
Petaluma, California 92954
United StatesSite Not Available
Site 109
Sacramento, California 94206
United StatesSite Not Available
Site 111
Grand Junction, Colorado 81501
United StatesSite Not Available
Site 103
Largo, Florida 33770
United StatesSite Not Available
Site 106
Oak Lawn, Illinois 60453
United StatesSite Not Available
Site 108
Alexandria, Minnesota 56308
United StatesSite Not Available
Site 104
Saint Louis, Missouri 63131
United StatesSite Not Available
Site 101
Somersworth, New Hampshire 03878
United StatesSite Not Available
Site 107
Sioux Falls, South Dakota 57108
United StatesSite Not Available
Site 110
San Antonio, Texas 78229
United StatesSite Not Available
Site 112
San Antonio, Texas 78229
United StatesSite Not Available
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