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Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

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ClinicalTrials.gov Identifier: NCT00349466
Recruitment Status : Completed
First Posted : July 7, 2006
Results First Posted : August 12, 2011
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

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.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: CF101 Drug: Placebo Phase 2

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 height, weight, sitting blood pressure, pulse rate and temperature, and clinical laboratory tests. Disease activity will be assessed using tear meniscus (TM) height, tear break-up time (BUT), fluorescein staining (FS), Schirmer test, and the Dry Eye Symptom Score (DESS). Doses of artificial tears must be stable for >2 weeks prior to the Screening Visit.

Eligible patients will begin a 2-week run-in period, during which time they will be instructed to discontinue use of all topical ophthalmic medications except for lubricant eye drops. Patients who successfully complete the 2-week run-in period will be randomized to their assigned medication (CF101 1 mg or matching placebo) to be taken orally every q12h for 12 weeks. Patients will return for assessments and a new supply of study medication at Weeks 2, 4, 8 and 12, and at Week 14 for a final follow-up assessment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Keratoconjunctivitis Sicca
Study Start Date : January 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: 1
CF101 1 mg given orally every 12 hours for 12 weeks
Drug: CF101
Orally CF101 1mg
Other Name: IB-MECA

Placebo Comparator: 2
Placebo given orally every 12 hours for 12 weeks
Drug: Placebo
Orally matching Placebo
Other Name: Inactive pill




Primary Outcome Measures :
  1. Schirmer Test (ST) [ Time Frame: 12 weeks ]
    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

  2. Tear Break-Up Time [ Time Frame: 12 weeks ]
    time elapsed between a complete blink and the development of the first random dry spot on the tear film

  3. Fluorescein Staining of the Cornea [ Time Frame: Baseline and 12 weeks ]
    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, expressed as number of participants with >25% improvement at Week 12 relative to baseline


Secondary Outcome Measures :
  1. Proportion of Clinical Success [ Time Frame: 12 weeks ]
    improvement of ≥25% over baseline at Week 12 in BUT, superficial punctate keratitis as assessed by FS, or ST

  2. Dry Eye Symptom Score [ Time Frame: 12 weeks ]
    consists of 12 questions designed to assess the symptoms of ocular irritations, covering three areas: ocular symptoms, environmental triggers and visionrelated function

  3. Tear Meniscus (TM) Height [ Time Frame: 12 weeks ]
    Indicator of tear volume. TM was recorded on a scale from 0-3, with 0=none, 1=trace, 2=normal, and 3=high.

  4. Use of Artificial Tears [ Time Frame: 12 weeks ]
    daily use of REFRESH TEARS® Lubricant Eye Drops artificial tears supplied to each patient was recorded in diaries provided to patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 years of age and over;
  • Have a diagnosis of moderate-to-severe KCS as defined by: (1) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349466


Locations
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Israel
Meir Hospital
Kfar-Saba, Israel, 44281
Sheba Medical Center
Tel Hashomer, Israel, 5262
Assaf Harofeh Medical Center
Zeriffin, Israel, 70300
Sponsors and Collaborators
Can-Fite BioPharma
Investigators
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Principal Investigator: Irit Bareket, MD Sheba Medical Center

Additional Information:
Publications of Results:
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Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00349466     History of Changes
Other Study ID Numbers: CF101-201KCS
First Posted: July 7, 2006    Key Record Dates
Results First Posted: August 12, 2011
Last Update Posted: March 4, 2015
Last Verified: August 2011
Keywords provided by Can-Fite BioPharma:
Keratoconjunctivitis Sicca
KCS
Dry Eye
Additional relevant MeSH terms:
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Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases