Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in adult males and females, aged 18 years and over, with a diagnosis of moderate-to-severe keratoconjunctivitis sicca (KCS). Patients will be randomized to receive either CF101 1 mg or matching placebo, given orally every 12 hours (q12h) for 12 weeks. A Screening Period of up to 4 weeks that includes a 2-week run-in period will precede a 12-week treatment period, followed by a 2-week follow-up period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Can-Fite BioPharma

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.