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.
OBJECTIVE
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.


CONCLUSIONS
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, Pavia, Italy. gemma.rossi.md@gmail.com
Gemma Caterina Maria
GC
Rossi
Gian Maria
GM
Pasinetti
Marta
M
Raimondi
Gabriella
G
Ricciardelli
Luigia
L
Scudeller
Mirella
M
Blini
Alberto
A
Amisano
Paolo Emilio
PE
Bianchi
D000368:Aged; D005260:Female; D005901:Glaucoma / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000523:psychology; D011460:Prostaglandins F / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016037:Single-Blind Method
D011460:Prostaglandins F; C485333:tafluprost