Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

NCT00349466 | Completed Phase 2 Results

• 1 other identifier: CF101-201KCS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Keratoconjunctivitis Sicca

Keywords

Keratoconjunctivitis Sicca; KCS; Dry Eye

Outcome Measures

Primary Outcomes (3)

• Change From Baseline to Week 12 in Schirmer Test (ST) Score in Millimeters

  Involved placing a standardized paper tear strip inside the lower eyelid for 5 minutes. The tear strip was then removed and the length of the strip that was wet from tears was measured in millimeters. Change from baseline is calculated. Scores range 0-35 mm, with higher scores indicating more (better) tear production.

  12 weeks

• Change From Baseline to Week 12 in Tear Break-Up Time (BUT) in Seconds

  Time elapsed between a complete blink and the development of the first random dry spot on the tear film as seen under fluorescent light. Change from baseline is calculated. Scores range 0-30 seconds, with higher scores indicating better tear composition and function.

  12 weeks

• Number of Subjects With >25% Improvement in Fluorescein Staining of the Cornea (FS) at Week 12

  Severity of corneal epithelial loss as graded by Fluorescein Staining of the cornea, assessed on a 0-4+ scale with 0 = none and 4+ = severe de-epithelialization (in other words, higher scores indicate worse disease), expressed as number of participants with \>25% improvement at Week 12 relative to baseline.

  12 weeks

Secondary Outcomes (4)

• Number of Subjects Experiencing Clinical Success at Week 12

  12 weeks

• Change From Baseline to 12 Weeks in Dry Eye Symptom Score (DESS)

  12 weeks

• Change From Baseline to Week 12 in Tear Meniscus (TM) Height

  12 weeks

• Percent Change From Baseline to Week 12 in the Use of Artificial Tears

  12 weeks

Study Arms (2)

CF101 1mg

EXPERIMENTAL

CF101 1 mg given orally every 12 hours for 12 weeks

Drug: CF101

Placebo

PLACEBO COMPARATOR

Placebo given orally every 12 hours for 12 weeks

Drug: Placebo

Interventions

CF101 DRUG

Orally CF101 1mg

Also known as: Piclidenoson

CF101 1mg

Placebo DRUG

Orally matching Placebo

Also known as: Inactive pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (3)

Meir Hospital

Kfar Saba, 44281, Israel

Location

Sheba Medical Center

Tel Litwinsky, 5262, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (1)

• Avni I, Garzozi HJ, Barequet IS, Segev F, Varssano D, Sartani G, Chetrit N, Bakshi E, Zadok D, Tomkins O, Litvin G, Jacobson KA, Fishman S, Harpaz Z, Farbstein M, Yehuda SB, Silverman MH, Kerns WD, Bristol DR, Cohn I, Fishman P. Treatment of dry eye syndrome with orally administered CF101: data from a phase 2 clinical trial. Ophthalmology. 2010 Jul;117(7):1287-93. doi: 10.1016/j.ophtha.2009.11.029. Epub 2010 Mar 20.

  PMID: 20304499 RESULT

Related Links

• Can-Fite BioPharma web site

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Interventions

CF101

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Pnina Fishman, PhD
• Organization: Can-Fite Biopharma

pnina@canfite.co.il

011972 3 924 1114

Study Officials

• Irit Bareket, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2006
• First Posted: July 7, 2006
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 9, 2022
• Results First Posted: August 12, 2011

Record last verified: 2022-02

Locations

IL (3)