A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy

The primary objective is to determine the effect of preoperative Miebo treatment on the accuracy of preoperative biometry/keratometry and predicted refraction in subjects with dry eye disease (DED) who are already scheduled for cataract surgery.

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 for cataract surgery (eligible eye can be a subject's second eye to undergo cataract surgery as long as all eligibility criteria are met in that eye)
• Candidate for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery)
• In the Investigator's opinion, subject has potential postoperative pinhole Snellen 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, and temporal), 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 trial assessments and visits.

Exclusion criteria

• Have any clinically significant ocular surface slit-lamp findings in the study eye 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 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 prior to Visit 1: Vuity®, Qlosi™, 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 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 (3 months for dissolvable punctum plugs) prior to Visit 1
• Use of any eye drops (prescription or over-the-counter, such as artificial tears or Lumify®) and/orTrueTear™ device (intranasal tear neurostimulator) in the study eye 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 in the study eye within 3 months prior to Visit 1; have undergone refractive surgery in the study eye 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 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 is expected to be unstable during the trial
• Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to 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.