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news.Oculus Innovative Sciences has completed patient treatment and follow-up in a randomized and controlled Phase II clinical trial evaluating its Microcyn technology in the treatment of mildly infected diabetic foot ulcers. The final patient evaluation occurred on December 24, 2007.
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The Phase II randomized, controlled open-label study enrolled a total of 67 patients with mildly infected diabetic foot ulcers at 15 US sites. Three treatment arms were evaluated: 1) topical Microcyn alone 2) topical Microcyn in combination with oral levofloxacin and 3) topical saline in combination with oral levofloxacin. The company expects to provide preliminary top line Phase II clinical trial results in first quarter of 2008.
Hoji Alimi, chairman and CEO of Oculus Innovative Sciences, said: “Our intent is to use the various data points in the Phase II trial as the foundation for moving the company’s clinical program forward.”