![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » OCULUS INNOVATIVE SCIENCES ANNOUNCES FIRST U.S. CLINICAL TRIAL ON HUMANS
OCULUS INNOVATIVE SCIENCES ANNOUNCES FIRST U.S. CLINICAL TRIAL ON HUMANS
June 27, 2005
Theresa Mitchell, vice president of regulatory and clinical affairs for Oculus Innovative Sciences, has announced that Oculus has initiated its first U.S. clinical trial on humans to gain approval for the Microcyn Technology to be marketed as an antimicrobial preoperative and preinjection skin preparation.
The company anticipates the technology to demonstrate both safety and efficacy, while remaining nonirritating and nontoxic.
This Phase I study includes 290 volunteers and is being conducted at BioSciences Laboratories in Bozman, Montana. Mitchell indicates the company expects significant clinical data from this study by fall of this year.
The company will also be initiating other clinical studies in Europe and the U.S. that it intends to announce this summer.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct