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news.Oculus Innovative Sciences has completed enrollment for a Phase II clinical trial evaluating its Microcyn technology in the treatment of mildly infected diabetic foot ulcers.
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The company has enrolled and randomized 67 patients in its open-label Phase II clinical trial that is being conducted at 15 US sites. The study is specifically designed to demonstrate that topical Microcyn has sufficiently similar cure and improvement rates to oral levofloxacin. The company expects to provide preliminary top line results in the first calendar quarter of 2008.
The trial is evaluating three different treatment arms: topical Microcyn alone; topical Microcyn in combination with oral levofloxacin; and oral levofloxacin plus topical saline. Each patient will receive 10 days of treatment with a 14-day follow-up. The designed assessment time points – day three, day 10, and day 24, allow for various options to analyze the data which will provide important information for the design of the Phase III trial.
Hoji Alimi, chairman and CEO of Oculus, said: “Completing enrollment for the Phase II trial is a major milestone for Oculus and our Microcyn Technology. We look forward to reporting preliminary top line data from the trial in the first calendar quarter of 2008.”