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Abstract #50525 Published in IGR 14-2

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

Rossi GC; Pasinetti GM; Raimondi M; Ricciardelli G; Scudeller L; Blini M; Amisano A; Bianchi PE
Expert Opinion on Drug Safety 2012; 11: 519-525

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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.

University Eye Clinic, IRCCS Policlinico San Matteo Foundation , P.le Golgi 19, 27100 Pavia , Italy +39 0382 503730 ; +39 0382 527006 ; gemma.rossi.md@gmail.com.

Full article

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Classification:

11.16 Vehicles, delivery systems, pharmacokinetics, formulation (Part of: 11 Medical treatment)
11.4 Prostaglandins (Part of: 11 Medical treatment)

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