Efficacy and ocular surface tolerability of preservative-free tafluprost 0.0015%: A 6-month, single-blind, observational study on naïve ocular hypertension or glaucoma patients

Gemma Caterina Maria Rossi, Gian Maria Pasinetti, Marta Raimondi, Gabriella Ricciardelli, Luigia Scudeller, Mirella Blini, Alberto Amisano, Paolo Emilio Bianchi

Research output: Contribution to journalArticle

Abstract

Objectives: The aim of this study was to evaluate the safety of preservative-free tafluprost in newly diagnosed patients and to confirm its efficacy in lowering intraocular pressure (IOP). Methods: Naïve patients were submitted to an ophthalmic examination, including ocular surface status and quality of life evaluation. All examinations were performed at baseline and after 1 and 6 months. Results: 28 patients were enrolled and treated with tafluprost, once a day, in the evening. TF-BUT changed from 9 (interquartile range (IQR) 6 - 11) s at baseline to 10 (IQR 7 - 10) s at 1 month (p = 0.106) and 9 (IQR 6 - 12) s at 6 months (p = 0.003). No eye developed corneal staining. Quality of life was (median (IQR)) 91.6 (79.2 - 95.8) at baseline and 95.8 (66.7 - 100) at 6 months (p = 0.62). Only a few adverse events occurred during the follow-up period (three patients experienced ocular burning and one developed redness). The mean IOP reduction was 5.5 mm Hg (95% CI =3.8 - 7.2). The median (IQR) baseline IOP was 18.7 (15 - 23.7) mm Hg; 14 (13 - 16) mm Hg and 16 (14 - 16) mm Hg (p <0.0001) after 1 and 6 months, respectively. Conclusion: No patient developed ocular surface disease and quality of life perception was preserved. Preservative-free tafluprost is therefore an effective drug that is safe for the ocular surface after 6 months of daily therapy.

Original languageEnglish
Pages (from-to)519-525
Number of pages7
JournalExpert Opinion on Drug Safety
Volume11
Issue number4
DOIs
Publication statusPublished - Jul 2012

Keywords

  • Efficacy
  • Glaucoma
  • Ocular surface
  • Quality of life
  • Tafluprost
  • Tolerability

ASJC Scopus subject areas

  • Pharmacology (medical)

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