Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

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.

Timeline

Start

2007-01

Primary completion

2009-05

Completion

2009-05

Outcome

Mixed primary results

registry LEAST_SQUARES_MEAN CF101 1 mg: 1.25 (Standard Error 0.765) Millimeters NCT00349466 ↗

registry LEAST_SQUARES_MEAN Placebo: 3.81 (Standard Error 0.814) Millimeters NCT00349466 ↗

registry analysis (superiority test); CF101 1 mg vs Placebo; p = 0.027; ANCOVA NCT00349466 ↗

registry LEAST_SQUARES_MEAN CF101 1 mg: 2.83 (Standard Error 0.906) seconds NCT00349466 ↗

registry LEAST_SQUARES_MEAN Placebo: 0.48 (Standard Error 0.083) seconds NCT00349466 ↗

registry analysis (superiority test); CF101 1 mg vs Placebo; p = 0.083; ANCOVA NCT00349466 ↗

registry NUMBER CF101 1 mg BID: 22 participants NCT00349466 ↗

registry NUMBER Placebo BID: 12 participants NCT00349466 ↗

registry analysis (unspecified test); CF101 1 mg BID vs Placebo BID; p = 0.028; Fisher Exact NCT00349466 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Piclidenoson	Small molecule	1 mg	Oral

Indications