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news.EyeGate Pharma has started a Phase I clinical study designed to assess the safety and tolerability of the non-invasive EyeGate II ocular drug delivery system in up to 95 healthy adult volunteers.
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This is a single center, randomized, single masked, comparative-group safety and tolerability study of a range of single iontophoretic dose levels with a citrate buffer via the EyeGate II delivery system. This Phase I study will build on an earlier study designed to assess the safety, tolerability, and efficacy of EyeGate’s first generation iontophoretic drug delivery device.
Mike Patane, chief scientific officer of EyeGate Pharma, said: “This GCP Phase I study is designed to establish the maximum tolerated current that can be employed during iontophoretic treatment with the EyeGate II delivery system. It is an important step in understanding the parameters of the technology prior to initiating two Phase II clinical trials planned for 2008 in severe uveitis and dry eye patients.”