Evaluation of the Efficacy and Safety of OC-01 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 symptoms within 6 months prior to Visit 1

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 twelve months of Visit 1.
• 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, conjunctivitis,or inflammation not associated with dry eye; anterior (epithelial) basement membranecorneal dystrophy or other clinically significant corneal dystrophy or degeneration;ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiringtreatment and mild meibomian gland disease that are typically associated with dry eyedisease are allowed.
• 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 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.