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M. Papadia, C.E. Traverso, A. Ropo, H. Uusitalo; A Pilot Phase Ii Study On The Extent, Duration Of Action And Stability Of The Iop Lowering Effect Of Tafluprost 0.0015%, A Novel Prostaglandin Analogue, As Compared To Latanoprost 0.005% . Invest. Ophthalmol. Vis. Sci. 2006;47(13):447.
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To investigate the intraocular pressure (IOP) lowering effect and the tolerability of tafluprost 0.0015% eye drops in comparison to latanoprost 0.005% eye drops in patients with open–angle glaucoma or ocular hypertension. The primary aim was to investigate the extent and duration of action up to 48 h after the last dose and the stability of the diurnal IOP curve.
This was a prospective, randomized, double–masked, active–controlled, parallel–group, multinational and multicenter pilot phase II study. Each patient was treated with either tafluprost 0.0015% or latanoprost 0.005% eye drops according to randomisation for 6 weeks. An appropriate wash–out period was required to abolish the effect of previous medication. RMANOVA, RMANCoVA and descriptive statistics for the primary and secondary efficacy variables were utilised . A 95% confidence interval for the overall treatment effect (tafluprost–latanoprost) from the above model was used. Descriptive statistics were used for safety and tolerability variables.
A total of 38 patients were enrolled;18 in each group completed the study. Efficacy results No statistically significant differences in the IOP lowering effect between tafluprost 0.0015% and latanoprost 0.005% eye drops were detected at the end of the 6–week treatment period, i.e. on Days 42 and 43, p=0.942 for overall treatment comparison. For both groups, the mean diurnal IOP decrease from baseline to Day 42 was 33%, an effect that was already seen on Day 7. The IOP values remained stable for both tafluprost and latanoprost up to at least 24 hours after dosing and started to slowly increase 36 hours after dosing. Safety and tolerability results Adverse events were very few, evenly distributed between the two treatment groups. Both tafluprost and latanoprost showed a relatively low incidence of conjunctival redness, which was mild in majority of the cases.
This pilot study shows that short–term IOP–lowering and safety characteristics of tafluprost eye drops are comparable to latanoprost: further clinical studies to confirm the long–term efficacy and safety of tafluprost eye drops are warranted.
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