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Status:

COMPLETED

Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

Lead Sponsor:

Can-Fite BioPharma

Conditions:

Keratoconjunctivitis Sicca

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 s...

Detailed Description

At a Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2009

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT00349466

Start Date

January 1 2007

End Date

May 1 2009

Last Update

May 9 2022

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Meir Hospital

Kfar Saba, Israel, 44281

2

Sheba Medical Center

Tel Litwinsky, Israel, 5262

3

Assaf Harofeh Medical Center

Ẕerifin, Israel, 70300