SYL040012. Tolerance And Effect On Intraocular Pressure .
... Results:
Local tolerance was excellent. No modifications of the ocular surface or iris were detected. The analytical results at final examination did not show differences from those observed during selection. There were statistical differences between area under curve (AUC) of IOP curves on day four with respect to selection day curve (12% decrease) in all volunteers administered with the low level dose of SYL040012 during seven days. Five of them (with an average basal value of IOP higher than the mean value for the whole group) showed reduction higher than 15%. SYL040012 was not detected in blood.
Conclusions:
The Phase I clinical trial for SYL040012 was completed in 30 healthy volunteers. SYL040012 showed excellent local and systemic tolerance after single and multiple administrations to subjects.