Overview

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.