Phase 1 study results

The ODAK project successfully completed a Phase 1 clinical study on 90 healthy volunteers in April 2016. This trial was a randomized, double-masked, placebo-controlled, multiple centre, parallel-group Phase 1 study to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic solution, compared to placebo, in healthy subjects. The study was conducted in three clinical centres in the Netherlands and Belgium. Volunteers were screened to ensure they met all the criteria for the trial and used the study medication (PHMB or placebo eye drops) for two weeks. Each volunteer visited the clinic several times in order to check whether the eye drops had any effect on their eyes or on routine blood tests. The subjects were also asked to report any possible side effects of the eye drops.

The study conclusions showed no major safety concerns with regard to multiple dosing, and doses of up to 0.08% PHMB were considered safe and tolerable in healthy subjects.