Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

Inclusion Criteria: * Be at least 18 years of age; * Provide written informed consent; * Have a subject reported history of dry eye for at least 6 months * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months * Have a Schirmer's Test score of ≤10mm and ≥1mm * Have a Tear Film Break-Up Time (TFBUT) ≤10 seconds * Have a corneal fluorescein staining score of ≥2 in at least one region of the cornea Exclusion Criteria: * Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months; * Have an IOP \> 25 mmHg at Visit 1; * Have any planned ocular and/or lid surgeries over the study period; * Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1; * Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); * Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;