title: Ocular Tolerability of Preservative-Free Tafluprost and Latanoprost: in vitro and in vivo Comparative Study.
abstract: OBJECTIVE
  Detrimental effects of the preserved prostaglandin analogs (PGAs) have been thoroughly documented in the published literature. The current work studied two preservative-free (PF) prostaglandin eye drops: PF tafluprost and PF latanoprost. The aim of the study was to compare these two PF formulations in vitro for viability of the human corneal epithelial (HCE-T) cells and in vivo for ocular tolerability of the rabbit eye.
  
  
  METHODS
  Viability of the HCE-T cells was measured by the MTS assay. The SV40-immortalized HCE-T cells were exposed to 100 µL of the drug solutions (at their commercial concentrations) or the culture medium. Ocular irritation was evaluated after repeated instillation of the drug solutions in Japanese white rabbits (Kbl:JW).
  
  
  RESULTS
  A significant loss of HCE-T cell viability was observed in vitro immediately after the exposure to PF latanoprost formulation but not immediately after the exposure to PF tafluprost formulation. Congruently, PF latanoprost induced in vivo more irritation on the rabbit eye than PF tafluprost.
  
  
  CONCLUSIONS
  Comparing these two PF formulations in vitro and in vivo, it is considered that ocular tolerability of PF tafluprost is better than PF latanoprost. Taking into account the composition of these two PF PGA formulations, the solubilizing agent macrogolglycerol hydroxystearate 40 (MGHS40) contained in PF latanoprost formulation is a plausible cause for the negative effects.
authors.affiliation: Santen Pharmaceutical Co, Ltd, Nara, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Esaki
authors.affiliation: Santen Pharmaceutical Co, Ltd, Nara, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Shimazaki
authors.affiliation: Santen Oy, Tampere, Finland.
authors.forename: Pertti
authors.initials: P
authors.lastname: Pellinen
keywords: Latanoprost; ocular tolerability; preservative-free; tafluprost