Trial of CF101 to Treat Patients With Dry Eye Disease

Inclusion Criteria: * Male or female, 18 years of age and over; * Have a diagnosis of moderate-to-severe Aqueous-Deficient Dry Eye (including Sjögren's Syndrome dry eye), as defined by: 1. Positive corneal fluorescein staining (FS), defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale; AND 2. FS score of ≥2 in at least one corneal region; AND 3. Schirmer Test (ST) score (without anesthesia) ≥1 mm and \< 7 mm/5 min in either eye; AND 4. OSDI score of ≥20; * Central corneal FS score of ≥2 in at least 1 eye; * Willing to use no topical ocular treatments, other than REFRESH® unpreserved artificial tears up to a maximum of 4 times daily, for the duration of the trial (including the 2-week run-in period, the 24-week treatment period and the 2-week follow-up period); * Willing to forego periocular cosmetic application for the duration of the trial; * Females of child-bearing potential must have a negative urine pregnancy test at screening and throughout the study, to be eligible for, and continue participation in, the study; * Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (for example oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study; * Ability to complete the study in compliance with the protocol; and * Ability to understand and provide written informed consent. Exclusion Criteria: * Sjögren's Syndrome with significant systemic non-exocrine gland involvement which, in the investigator"s opinion, would interfere with the conduct of the trial; * Stevens-Johnson Syndrome; * Use of methotrexate or systemic cyclosporine within the 3 months prior to the Screening Visit; * of any other disease-modifying anti-rheumatic therapy within 2 months prior to the Screening Visit; * Use of any anti-rheumatic biological agent within 2 months, or 5 half-lives, whichever is longer, prior to the Screening Visit; * Use of oral corticosteroids \>10 mg prednisone, or equivalent, per day; * Use of topical steroids within 4 weeks prior to the Screening Visit and for the duration of the study; * Receipt of topical cyclosporine eye drops within 3 months prior to the Screening Visit and for the duration of the trial; * Use of oral statin or preparation containing omega-3 fatty acid unless dose has been stable for at least 3 months and will remain so during the course of the trial; * Presence of chronic ocular disease other than Aqueous-Deficient Dry Eye requiring topical treatment; * Presence of post-burn ocular injury; * Ocular herpes simplex virus infection; * Concomitant use of contact lenses or use within 3 months prior to the Screening Visit; * Persistent intraocular inflammation or infection; * Active anterior blepharitis of greater than mild degree, defined as minimal crust at the base of the eyelashes and no signs of inflammation; * Meibomian gland dysfunction (MGD) of greater than mild degree, defined as mild plugging of the Meibomian glands without lid margin inflammation; * Surgical occlusion of the lacrimal puncta, including the insertion of punctual plugs, within 3 months of the Screening Visit.