Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK)

Inclusion Criteria:

• Be willing and able to sign the informed consent form (ICF)
• Be at least 18 years of age at the screening visit
• Be undergoing LASIK treatment in one or both eyes
• Be myopic between -1.00D to -7.00D MRSE (manifest refraction spherical equivalent) instudy eye (right eye) with ≤2D between eyes or subjects undergoing monovisiontreatment with study eye (distance eye) meeting the diopter requirement of myopia
• Be literate and able to complete questionnaires independently
• Be able and willing to use the study drug and participate in all study assessments andvisits
• Have sufficient hand strength, in the opinion of the Investigator, to be able toindependently administer the study drug
• Have provided verbal and written informed consent
• If a female is of childbearing potential, they must: use an acceptable means of birthcontrol (acceptable methods of contraception include: hormonal - oral, implantable,injectable, or transdermal contraceptives, mechanical - spermicide in conjunction witha barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner),and have a negative urine pregnancy test on baseline

Exclusion Criteria: Subjects must not:

• Have a break in the integrity of the corneal epithelium such as a persistent cornealepithelial defect, or corneal ulcer.
• Have presence of corneal pathology that may interfere with LASIK outcomes
• Active infectious, ocular or systemic disease
• Have a history of ocular inflammation or macular edema
• Have had clinically significant active infectious keratitis in the past 3 months
• Have history of prior refractive surgery
• Have placement of temporary punctal plugs in the past 1 month or current presence ofpermanent punctal plugs at time of screening
• Have chronic or recurrent epistaxis, coagulation disorders or other conditions that,in the opinion of the Investigator, may lead to clinically significant risk ofincreased bleeding
• Have had nasal or sinus surgery (including history of application of nasal cautery) orsignificant trauma to these areas
• Have a vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, orsevere nasal obstruction as confirmed by intranasal examination performed at Visit 1.
• Be currently treated with nasal continuous positive airway pressure
• Have had blepharoplasty in either eye
• Have had a corneal transplant in either eye
• Have a history of seizures or other factors that lower the subject's seizurethreshold.
• Have a systemic condition or disease not stabilized or judged by the Investigator tobe incompatible with participation in the study or with the lengthier assessmentsrequired by the study (e.g., current systemic infection, uncontrolled autoimmunedisease, uncontrolled immunodeficiency disease, history of myocardial infarction orheart disease, etc.)
• Have a known hypersensitivity to any of the procedural agents or study drug components
• Have current concomitant use of a nicotinic acetylcholine receptor agonist [Nicoderm®,Nicorette®, Nicotrol NS® (nicotine), Tabex®, Desmoxan® (cytisine), and Chantix® (varenicline)] within the previous 30 days of Visit 1 and during the treatment period.
• Have current concomitant use of snuff, chewing tobacco, e-cigarettes orcigarettes/cigars during the study or within the previous 30 days.
• Subject must refrain from smoking during the course of the study.
• Have active or uncontrolled, severe at the discretion of the investigator:
• Systemic allergy
• Chronic seasonal allergies at risk of being active during the study treatmentperiod
• Rhinitis or sinusitis requiring treatment such as antihistamines, decongestants,oral or aerosol steroids at the Screening Visit or be expected to requiretreatment during the treatment period of the study
• Untreated nasal infection at Visit 1
• Have any condition or history that, in the opinion of the investigator, may interferewith study compliance, outcome measures, safety parameters, and/or the general medicalcondition of the subject
• Be currently enrolled in an investigational drug or device study or have used aninvestigational drug or device within 30 days prior to Visit 1 and during thetreatment period.
• Be a female who is pregnant, nursing, or planning a pregnancy at Visit 1. Be a womanof childbearing potential who is not using an acceptable means of birth control;acceptable methods of contraception include: hormonal - oral, implantable, injectable,or transdermal contraceptives; mechanical - spermicide in conjunction with a barriersuch as a diaphragm or condom; IUD; or surgical sterilization of partner orhysterectomy. A woman that has not had a menses in 12 months or longer is notconsidered of childbearing potential.