A 6Month Study Comparing Efficacy Safety and To

Authors: Norbert Pfeiffer Carlo E Traverso Katrin Lorenz Ville Saarela Johanna Liinamaa Hannu Uusitalo Yury Astakhov Ernest Boiko Auli Ropo

Publish Date: 2014/12/02

Volume: 31, Issue: 12, Pages: 1228-1246

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Abstract

The efficacy safety and tolerability of the preservativefree PF fixed combination FC of tafluprost 00015 and timolol 05 once daily were compared to those of the individual components PF tafluprost 00015 once daily and PF timolol 05 twice daily in patients with openangle glaucoma or ocular hypertension inadequately controlled on prior timolol or prostaglandin monotherapy for 6 monthsA stratified doublemasked randomized multicenter phase III study was conducted A total of 189 prior timolol users were randomized within the timolol stratum TS to receive either FC n = 95 or timolol 05 TIM n = 94 Furthermore a total of 375 prior prostaglandin analog PGA users were randomized within the prostaglandin stratum PS to receive either FC n = 188 or tafluprost 00015 TAF n = 187 To be eligible for participation in the study the patients were required to have an intraocular pressure IOP of ≥22 mmHg when on timolol TIM or of ≥20 mmHg when on PGA in either treated eye at the screening and endofrunin visits In addition to these the study included visits at baseline 2 and 6 weeks 3 and 6 months and at a poststudy visit IOP was measured at 8 am 10 am 4 pm and 8 pmIn the TS a significant reduction from baseline IOP was seen with FC and TIM throughout the study Average diurnal IOP change from baseline at month 3 was −855 mmHg 32 for FC and −735 mmHg 28 for TIM The modelbased treatment difference FC–TIM was −0885 mmHg 95 confidence interval CI −1745 to −0024 p = 0044 demonstrating the superiority of FC over TIM In the PS a significant reduction in IOP was seen with both FC and TAF throughout the study The average diurnal IOP change from baseline at month 3 was −861 mmHg 33 for FC and −723 mmHg 28 for TAF The modelbased treatment difference FC–TAF was −1516 mmHg 95 CI −2044 to −0988 p  0001 demonstrating the superiority of FC over TAF In the TS related ocular adverse events AEs were more frequent for patients treated with FC compared to TIM 168 versus 64 whereas related nonocular AEs were more frequent with TIM compared to FC 21 versus 00 In the PS AEs were similarly distributed between FC and TAF The frequency of conjunctival hyperemia of FC was low 64The preservativefree fixed combination of tafluprost and timolol provided a substantial and significant IOP reduction in both strata The IOP reduction was superior to both tafluprost 00015 and timolol 05 when given as monotherapies Overall the study treatments were safe and well tolerated

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