Ensayo iniciado en Junio del 2011 y realizado en la Clinica Univeritaria de Navarra . El SYL1001 DP es un producto que se presenta como colirio para aplicación tópica desarrollado para el tratamiento o prevención del dolor ocular, bien asociado en algunas ocasiones a alguna patología como el síndrome de ojo seco, síndrome de Sjögren, etc, o bien producido por algún otro trauma o herida en la cornea, intentando minimizar el dolor ocular y mejorando de esta manera la calidad de vida del paciente. El SYL1001 es formulado en 2 gotas oftálmicas, en solución estéril, isotónica, a pH fisiológico, en viales monodosis evitando que haya que incorporar en la formulación conservantes antimicrobianos.****************************
... Results: In vitro and in vivo studies successfully demonstrated that ocular topical administration of SYL1001 was able to reduce TRPV1 levels and ocular pain in New Zealand white rabbits. Moreover, topical administration of SYL1001 prevents ocular pain after pain induction by capsaicin with a similar or higher analgesic effect than the reference analgesic standard. The toxicology experiments performed with SYL1001 by ocular topical route to dogs and rabbits indicated that no side effects were observed during 28-days of treatment. Pharmacokinetic analysis showed that no drug was detected above the detection limit (40 ng/mL) at any time or dose tested.
Conclusions: SYL1001 specifically directed to silence the TRPV1 gene appears to decrease the behavioural response to ocular surface irritation evoked by ocular capsaicin. These channels are involved in the nerve impulse responses to exogenous and endogenous substances mediating inflammation and pain. Toxicology results indicated that SYL1001 did not produce any adverse events related to treatment. SYL1001 has been demonstrated to be safe and efficient in recommended animal models, which suggest this product could be a very good candidate for treatment of ocular pain. ...