PETALUMA, Calif.--(BUSINESS WIRE)--Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) today announced completion of enrollment of its Phase II clinical trial of Microcyn® Technology. The company has enrolled and randomized 67 patients in its open-label Phase II clinical trial evaluating its Microcyn Technology in the treatment of mildly infected diabetic foot ulcers. The study, which is being conducted at 15 U.S. sites, is specifically designed to demonstrate that topical Microcyn has sufficiently similar cure and improvement rates to oral levofloxacin. This would provide the rationale for larger Phase III trials designed to demonstrate statistically significant safety and efficacy, fundamental in securing NDA marketing approval. Also being examined are a number of other trial parameters for consideration in the design of the larger Phase III trials that will be required for FDA approval. The company expects to provide preliminary top line results in the first calendar quarter of 2008.
