Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease

Inclusion Criteria:

• Have used and/or desired to use an artificial tear substitute for dry eye symptomswithin 6 months prior to the Screening Visit

Exclusion Criteria:

• Have had any intraocular surgery (such as cataract surgery) or extraocular surgery ineither eye within three months or refractive surgery (e.g., laser-assisted in-situkeratomileusis, laser epithelial keratomileusis, photorefractive keratectomy orcorneal implant) within 12 months of the Screening Visit
• Have a history or presence of any ocular disorder or condition in either eye thatwould, in the opinion of the Investigator, likely interfere with the interpretation ofthe study results or participant safety such as significant corneal or conjunctivalscarring; pterygium or nodular pinguecula; current ocular infection, acuteconjunctivitis, or inflammation not associated with dry eye; anterior (epithelial)basement membrane corneal dystrophy or other clinically significant corneal dystrophyor degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitisnot requiring treatment and mild meibomian gland disease that are typically associatedwith DED are allowed.
• Have a systemic condition or disease not stabilized or judged by the Investigator tobe incompatible with participation in the study (e.g., current systemic infection,uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history ofmyocardial infarction or heart disease, etc.)
• Have a known hypersensitivity to any of the procedural agents or investigationalproduct components
• 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.