A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK

Inclusion criteria

• Be at least 18 years of age at the time of consent, able to provide written voluntary informed consent, willing to follow instructions and participate in all trial assessments and visits
• Be a candidate for routine, uncomplicated bilateral LASIK surgery (for spherical equivalent [≤-8.00D] myopia or myopic astigmatism correction, not combined with any other procedure; monovision myopic targets are allowed, however the myopic target eye will be the non-study [fellow] eye)
• No history of refractive surgery including implantable Collamer lens (ICL) or cataract surgery
• Total CFS score ≥1 and ≤6 using the National Eye Institute scale at Visit 1 (in at least one eye)
• Ocular Surface Disease Index (OSDI) ≥13 and ≤22 at Visit 1

Exclusion criteria

• Have any clinically significant ocular surface slit-lamp findings in the study eye that, in the opinion of the Investigator, could interfere with outcomes of a routine, uncomplicated LASIK surgery, including but not limited to:

• History of eye trauma/surgery within the last 6 months that resulted in corneal scarring
• DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells, Stevens-Johnson syndrome, active blepharitis, or lid margin inflammation
• Abnormal cornea (e.g., keratoconus or corneal epithelial defect, pterygium, or history of herpetic keratitis)
• Use of any of the following ocular therapies in the study eye within 30 days prior to Visit 1: topical ocular steroid treatments, prescription dry eye therapy (including nasal spray), or topical intraocular pressure-lowering medications
• Use of any eye drops (prescription or over the counter) in the study eye within 24 hours prior to Visit 1
• Use of any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial
• Had a LipiFlow®, intense pulsed light (IPL) therapy, etc. 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
• Have worn soft contact lenses within either 3 days prior to the study or rigid gas-permeable contact lenses for 1 month prior to Visit 1 or any 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 ocular allergies that are/expected to be active during the trial period
• Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
• Have any ocular findings or uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
• 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 a known allergy and/or sensitivity or lack of desired efficacy in response to the investigational drug
• Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 30 days prior to Visit 1 -