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

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.

Keywords::

• efficacy
• glaucoma
• ocular surface
• quality of life
• tafluprost
• tolerability

Acknowledgment

Preliminary data have been accepted as an oral presentation at the International Symposium on Ocular Pharmacology and Therapeutics, ISOPT, in Wien, 1 – 4 December 2011.

Notes

This box summarizes key points contained in the article.