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) 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.