Intervention: Piclidenoson
Trial phase: Phase 2
SMILES: CNC(=O)[C@H]1O[C@@H](n2cnc3c(NCc4ccc(I)cc4)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: CF101 1 mg q12 hours
Eligibility criteria:
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.