Clinical Trial: Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 K

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.

Detailed Summary:

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.


Sponsor: Can-Fite BioPharma

Current Primary Outcome:

  • 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
  • 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
  • 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


Original Primary Outcome:

  • Teat Meniscus Height
  • Tear Break-Up Time
  • Fluorescein Staining for superficial punctate keratitis
  • Schirmer Test


Current Secondary Outcome:

  • 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
  • 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
  • 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.
  • 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


Original Secondary Outcome: Dry Eye Symptom Score

Information By: Can-Fite BioPharma

Dates:
Date Received: July 6, 2006
Date Started: January 2007
Date Completion:
Last Updated: February 12, 2015
Last Verified: August 2011