Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

Inclusion Criteria: Male or female, 18 years of age and over; Have a diagnosis of moderate-to-severe KCS as defined by: (1) Schirmer Test (ST) (without anesthesia) < 7 mm/5 min in either eye; AND (2) Positive FS, defined as a corneal punctate fluorescein staining score of ≥1 in either eye, where 0 = none and 3= severe; AND (3) At least 1 of the following ocular symptoms scored at ≥2, where 0 = none and 4 = very severe/interferes with normal activities: photophobia, blurred vision, foreign body sensation, soreness or pain, itching, burning, dryness; Willing to use no topical ocular treatments except for the unpreserved artificial tears; Doses of unpreserved artificial tears have been stable for >2 weeks prior to Screening Visit; 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: Has Sjögren's Syndrome with significant systemic non-exocrine gland involvement; Has Stevens-Johnson Syndrome; If KCS is due to rheumatoid arthritis or other autoimmune diseases, patient may not be receiving disease-modifying drugs, including methotrexate and biological agents; Use of systemic immunosuppressive drugs; Use of oral corticosteroids >10 mg prednisone, or equivalent, per day; Use of topical steroids within 2 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; Presence of chronic ocular disease other than KCS requiring topical treatment; Presence of post-burn ocular injury; Ocular herpes simplex virus infection; Concomitant use of contact lenses; Persistent intraocular inflammation or infection; Active blepharitis; Recent surgical occlusion of the lacrimal puncta; Subepithelial corneal scarring; Anesthetic or neurotrophic corneas; Hemoglobin level <9.0 gm/L; Platelet count <125,000/mm^3; White blood cell count <3500/mm^3; Serum creatinine level outside the laboratory's normal limits; Liver aminotransferase levels greater than 2 times the laboratory's upper limit of normal; Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator; History of malignancy within the past 5 years (excluding basal cell carcinoma of the skin); Significant acute or chronic medical, ophthalmic, or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study; Participation in another investigational drug or vaccine trial concurrently or within 30 days; or Other conditions which would confound the study evaluations or endanger the safety of the patient.