A 6-Month Study Comparing Efficacy, Safety, and Tolerability of the Preservative-free Fixed Combination of Tafluprost 0.0015% and Timolol 0.5% versus Each of Its Individual Preservative-Free Components

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• 作者：Norbert Pfeiffer (1)
  Carlo E. Traverso (2)
  Katrin Lorenz (1)
  Ville Saarela (3)
  Johanna Liinamaa (3)
  Hannu Uusitalo (4)
  Yury Astakhov (5)
  Ernest Boiko (6)
  Auli Ropo (7)
  
• 关键词：Glaucoma ; Fixed combination ; Preservative free ; Preservatives ; Prostaglandins ; Tafluprost ; Timolol
• 刊名：Advances in Therapy
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：31
• 期：12
• 页码：1228-1246
• 全文大小：717 KB
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• 作者单位：Norbert Pfeiffer (1)
  Carlo E. Traverso (2)
  Katrin Lorenz (1)
  Ville Saarela (3)
  Johanna Liinamaa (3)
  Hannu Uusitalo (4)
  Yury Astakhov (5)
  Ernest Boiko (6)
  Auli Ropo (7)
  
  1. Department of Ophthalmology, Mainz University Medical Center, Langenbeckstr. 1, 55101, Mainz, Germany
  2. Clinica Oculistica, Di.N.O.G.M.I., University of Genoa, IRCCS Azienda Ospedaliera Universitaria San Martino-IST, Genoa, Italy
  3. Department of Ophthalmology, Medical Research Center, Oulu University Hospital, University of Oulu, Oulu, Finland
  4. Department of Ophthalmology, University of Tampere and TAUH Eye Center, Tampere, Finland
  5. First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia
  6. Military Medical Academy, St. Petersburg, Russia
  7. Santen Oy, Clinical Research and Medical Affairs, Helsinki, Finland
  
• ISSN：1865-8652

文摘

Introduction The efficacy, safety and tolerability of the preservative-free (PF) fixed combination (FC) of tafluprost 0.0015% and timolol 0.5% (once daily) were compared to those of the individual components (PF tafluprost 0.0015% once daily and PF timolol 0.5% twice daily) in patients with open-angle glaucoma or ocular hypertension inadequately controlled on prior timolol or prostaglandin monotherapy for 6?months. Methods A stratified, double-masked, 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 0.5% (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 0.0015% (TAF; n?=?187). To be eligible for participation in the study, the patients were required to have an intraocular pressure (IOP) of??2?mmHg when on timolol (TIM) or of??0?mmHg when on PGA in either treated eye at the screening and end-of-run-in visits. In addition to these, the study included visits at baseline, 2 and 6?weeks, 3 and 6?months and at a post-study visit. IOP was measured at 8 a.m., 10 a.m., 4 p.m., and 8 p.m. Results In 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 ?.55?mmHg (32%) for FC and ?.35?mmHg (28%) for TIM. The model-based treatment difference (FC–TIM) was ?.885?mmHg [95% confidence interval (CI) ?.745 to ?.024; p?=?0.044] 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 ?.61?mmHg (33%) for FC and ?.23?mmHg (28%) for TAF. The model-based treatment difference (FC–TAF) was ?.516?mmHg (95% CI ?.044 to ?.988; p? Conclusion The preservative-free fixed combination of tafluprost and timolol provided a substantial and significant IOP reduction in both strata. The IOP reduction was superior to both tafluprost 0.0015% and timolol 0.5% when given as monotherapies. Overall, the study treatments were safe and well tolerated. Funding Santen Oy, Tampere, Finland.