Abstract
Results: :
Statistically significant increases in corneal staining was observed at 2 months after the initiation of the study (p=.025) between the two eyes, with those that received travoprost without BAC having the most staining. The OSDI survey also showed a trend of more dryness and irritation symptoms in the eyes receiving travoprost without BAC (P=.095). No significant difference in tear break-up times, IOP, Va, or Schirmer testing was observed. The intraocular pressure and vision were also not significantly affected by the different formulations. No significant adverse events or reactions occurred during the study and only one patient developed an IOP difference greater than 2mmHg between the two eyes.
Conclusions: :
Eyes receiving the prostaglandin travoprost without BAC unexpectedly showed a trend toward increased dryness and irritation with a significant difference in staining compared to the eyes remaining on latanoprost with the preservative BAC. Therefore, the change to travaprost that uses the new ionic buffered preservative system, SOFZIA TM instead of BAC may actually precipitate more ocular surface irritation overtime.
Clinical Trial: :
www.clinicaltrials.gov FWH20080020H
Keywords: cornea: tears/tear film/dry eye • quality of life • ocular irritancy/toxicity testing