Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The RAINIER Study)

Inclusion Criteria:

- Have used and/or desired to use an artificial tear substitute for dry eye symptoms
within 60 days prior to Visit 1

Exclusion Criteria:

- Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser
epithelial keratomileusis, laser-assisted in-situ keratomileusis, photorefractive
keratectomy or corneal implant) within twelve months of Visit 1

- Have a history or presence of any ocular disorder or condition in either eye that
would, in the opinion of the Investigator, likely interfere with the interpretation of
the study results or participant safety such as significant corneal or conjunctival
scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
or inflammation not associated with dry eye; anterior (epithelial) basement membrane
corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
treatment and mild meibomian gland disease that are typically associated with DED are
allowed.

- Have a systemic condition or disease not stabilized or judged by the Investigator to
be incompatible with participation in the study or with the lengthier assessments
required by the study (e.g., current systemic infection, uncontrolled autoimmune
disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
heart 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 interfere
with study compliance, outcome measures, safety parameters, and/or the general medical
condition of the subject