Original articleTreatment of Dry Eye Syndrome with Orally Administered CF101: Data from a Phase 2 Clinical Trial
Section snippets
Study Design
This report describes a randomized, multicenter, doubled-masked, placebo-controlled, parallel-group phase 2 clinical study that examined the safety and efficacy of daily CF101 administered orally in patients with moderate to severe dry eye syndrome. The study was composed of a screening period of up to 4 weeks, which included a 2-week run-in period, followed by a 12-week treatment period and a 2-week follow-up. The study was conducted in 5 investigative sites in Israel, in compliance with good
Participant Flow and Follow-up
A total of 101 patients were screened for the study; 21 failed the run-in period and dropped out before treatment. Eighty patients entered the study, 38 in the placebo group and 42 in the CF101-treated group, and 85% (68/80) completed the study (Table 1). The first patient was enrolled in November 2008, and the last patient completed the 12-week treatment and 2-week follow up in May 2009. Patient disposition is presented in Table 1.
Patient Demographics and Characteristics at Baseline
All the patients were white. Most patients were women (49/76
Discussion
This study presents data showing that CF101, administered orally, induced a statistically significant short-term improvement in the corneal staining in patients with moderate to severe dry eye syndrome. An improvement in the tear film BUT and TM also was observed. CF101 was well tolerated with no severe adverse events and a safety profile consistent with that reported in previous trials.23
In patients treated with CF101, the corneal staining scores were significantly lower at end point compared
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Cited by (0)
Manuscript no. 2009-1113.
Financial Disclosure(s): The author(s) have made the following disclosure(s):
Isaac Avni - Equity Owner - Can-Fite BioPharma
Sari Fishman - Employee - Can-Fite BioPharma
Zivit Harpaz - Employee - Can-Fite BioPharma
Motti Farbstein - Employee - Can-Fite BioPharma
Sara Bar Yehuda - Employee - Can-Fite BioPharma
Michael H. Silverman - Employee - Can-Fite BioPharma
William D. Kerns - Employee - Can-Fite BioPharma
Ilan Cohn - Employee - Can-Fite BioPharma
Pnina Fishman - Employee - Can-Fite BioPharma
Sponsored by Can-Fite BioPharma Ltd, Petach Tikva, Israel. Supported in part by the Intramural Research Program of the National Institute of Diabetes & Digestive & Kidney Diseases, National Institutes of Health, Bethesda, Maryland.