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Auli Ropo - One of the best experts on this subject based on the ideXlab platform.

  • changes in ocular signs and symptoms in patients switching from bimatoprost timolol to Tafluprost timolol eye drops an open label phase iv study
    BMJ Open, 2019
    Co-Authors: Kai Kaarniranta, Carlo Enrico Traverso, Rupert R A Bourne, Katrin Lorenz, Jouni Vuorinen, Auli Ropo
    Abstract:

    Objectives Bimatoprost–timolol (bimatoprost 0.03%–timolol 0.5% fixed-dose combination [FDC]) and Tafluprost–timolol (Tafluprost 0.0015%–timolol 0.5% FDC) eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservative-free (PF) prostaglandin and timolol FDC. The aim of this study was to investigate changes to ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or benzalkonium chloride (BAK)-preserved bimatoprost–timolol to PF Tafluprost–timolol eye drops. Design This was a 12-week, open-label, phase IV study. Setting Sixteen centres in Finland, Germany, Italy and the UK. Participants Patients with OH or OAG (IOP on medication ≤21 mm Hg), treated with PF or BAK-preserved bimatoprost–timolol for ≥4 weeks before screening, and presenting with conjunctival hyperaemia and ≥1 ocular symptom. Interventions Patients were switched to PF Tafluprost–timolol once daily in the treated eye(s). Primary and secondary outcome measures The primary endpoints were change from screening to week 12 in conjunctival hyperaemia and worst ocular symptom. The secondary outcome measures were changes from screening in ocular signs (other than conjunctival hyperaemia) and symptoms at week 12. Results Of 123 enrolled patients, 121 were included in the intention-to-treat dataset, of which all were Caucasian and 54.5% were female; 76 patients used BAK-preserved bimatoprost–timolol and 45 used PF drops. Conjunctival hyperaemia and severity of worst ocular symptom following switch to PF Tafluprost–timolol significantly reduced from screening to week 12 in all patients (p Conclusions Switching from BAK-preserved or PF bimatoprost–timolol to Tafluprost–timolol reduced both signs and symptoms of ocular surface disease with no clinically relevant effect on IOP. Trial registration number EudraCT2014-005273-37; Results.

  • preservative free fixed combination of Tafluprost 0 0015 and timolol 0 5 in patients with open angle glaucoma and ocular hypertension results of an open label observational study
    Clinical Ophthalmology, 2017
    Co-Authors: L E Pillunat, Auli Ropo, C Erb, F Kimmich, Norbert Pfeiffer
    Abstract:

    Background Efficacy, tolerability and safety of the novel preservative-free fixed combination of Tafluprost 0.0015%/timolol 0.5% (Taptiqom®) were investigated in an observational study in Germany. Objective To assess efficacy, tolerability and safety of the preservative-free fixed combination of Tafluprost 0.0015%/timolol 0.5% in a real-life setting. Methods Intraocular pressure (IOP) was recorded for each eye at baseline (any previous therapy or untreated) and 4-16 weeks after changing medical treatment to or initiating treatment with the preservative-free fixed combination of Tafluprost 0.0015%/timolol 0.5%. Change in IOP was evaluated over the study period for all patients and for specific pretreatment subgroups. Clinical signs such as conjunctival hyperemia and lid-parallel conjunctival folds (LIPCOF) were recorded using standardized comparative photographs. Corneal staining, subjective symptoms and local comfort were measured using a four-step scale. All adverse events were recorded. Results Among 1,157 patients enrolled, 1,075 patients were treated with the preservative-free fixed combination as the only medication at the final visit. Medical treatment was initiated in 741 patients because of an insufficient IOP-lowering effect of the prior medication. In 343 patients, medication was changed because of tolerability issues. The preservative-free fixed combination lowered IOP significantly in the subgroup of naive patients, all subgroups with prior monotherapy and patients with prior fixed combinations: naive patients: -8.9 mmHg, alpha- 2-agonists: -6.4 mmHg, beta-blockers: -5.7 mmHg, carbonic anhydrase inhibitors: -5.2 mmHg, prostaglandins: -4.7 mmHg, fixed-combination prostaglandins/timolol: -2.4 mmHg. At the final visit, clinical signs and subjective symptoms were improved in patients with prior medical therapy. Local comfort was rated as "very good" or "good" by 89.1% of patients at the final visit. Only few adverse events occurred during the treatment period. Conclusion The preservative-free fixed combination of Tafluprost 0.0015%/timolol 0.5% was effective, well tolerated and showed a good safety profile.

  • pharmacokinetics efficacy and safety of the preservative free fixed combination of Tafluprost 0 0015 and timolol 0 5 in healthy volunteers a phase i comparison vs the corresponding preservative free monotherapies
    Clinical Pharmacokinectics, 2016
    Co-Authors: Kai Kaarniranta, Kirsi Ikaheimo, Eliisa Mannermaa, Auli Ropo
    Abstract:

    Plasma concentrations of Tafluprost acid and timolol were compared after single (Day 1) and repeated (Day 8) instillations of once-daily Tafluprost 0.0015 %-timolol 0.5 % preservative-free (PF) fixed-dose combination (FDC), once-daily PF Tafluprost 0.0015 %, and twice-daily PF timolol 0.5 %. Fifteen healthy volunteers were randomized to this double-masked, single-center, three-period cross-over study. A wash-out interval of at least 4 weeks separated each three 8-day dosing period. Blood samples were drawn on the first and last day of each dosing period, prior to the morning dose, as well as 5, 10, 15, 30, and 45 min, and 1, 1.5, 2, 4, 8, and 12 h post-dosing. Sample plasma concentrations of Tafluprost acid and/or timolol were determined and maximum concentration (C max), area under the concentration-over-time curve from time zero to the last time point with a quantifiable measurement (AUC0–last), and time to maximum concentration were calculated. Intraocular pressure (IOP), adverse events, and ocular/systemic safety variables were also evaluated. Plasma concentrations of Tafluprost acid were low, with similar levels measured subsequent to either single or repeated dosing of PF FDC and PF Tafluprost. On both sampling days, concentrations peaked at 10 min after the dose, and were cleared from the blood circulation by 30 min; average C max ranged from 17 to 24 pg/mL, and AUC0–last from 3 to 5 pg*h/mL. Plasma concentrations of timolol were comparable after the first dose of PF FDC or PF timolol. Concentrations peaked at 15 min post-dose and diminished in a similar manner after 2 h; average C max was 800 pg/mL and AUC0–last 3900 pg*h/mL. As expected, PF timolol produced a higher Day 8 pre-dose timolol concentration than PF FDC (235 vs. 37 pg/mL; p < 0.001, respectively). The Day 8 post-dose changes in timolol concentrations were relative to this pre-dose difference. All study treatments were well tolerated and safe. PF FDC seemed to provide the best IOP reduction. PF FDC demonstrated good IOP-lowering efficacy and displayed similar pharmacokinetic characteristics to the monotherapy agents. Exposure to timolol was reduced via the halved dosing.

  • intraocular pressure decrease with preservative free fixed and unfixed combination of Tafluprost and timolol in pseudoexfoliative glaucoma
    Current Medical Research and Opinion, 2015
    Co-Authors: Gabor Hollo, Auli Ropo
    Abstract:

    We investigated the intraocular pressure (IOP) lowering efficacy of preservative-free fixed and non-fixed combination of Tafluprost 0.0015% and timolol 0.5% in pseudoexfoliative glaucoma (XFG). A per protocol worse eye analysis was made on all XFG patients who participated in a recent 6 month, prospective, randomized, double-masked, parallel group, multicenter phase III study. The mean time-wise IOP decreased by 8.62 to 10.25 mmHg (31.8 to 36.7%) in the fixed dose combination arm (15 patients) and by 5.38 to 11.35 mmHg (21.3 to 41.2%) in the non-fixed combination arm (13 patients), respectively (p < 0.001 for all comparisons). The results show that a preservative-free fixed dose combination of Tafluprost and timolol provides a clinically significant IOP reduction in XFG, and may offer an advantage for the XFG patients with dry eye, due to its preservative-free nature.

  • 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
    Advances in Therapy, 2014
    Co-Authors: Norbert Pfeiffer, Hannu Uusitalo, Carlo Enrico Traverso, Katrin Lorenz, Ville Saarela, Johanna Liinamaa, Yury S Astakhov, Ernest V Boiko, Auli Ropo
    Abstract:

    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. 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 ≥22 mmHg when on timolol (TIM) or of ≥20 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. 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 −8.55 mmHg (32%) for FC and −7.35 mmHg (28%) for TIM. The model-based treatment difference (FC–TIM) was −0.885 mmHg [95% confidence interval (CI) −1.745 to −0.024; 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 −8.61 mmHg (33%) for FC and −7.23 mmHg (28%) for TAF. The model-based treatment difference (FC–TAF) was −1.516 mmHg (95% CI −2.044 to −0.988; p < 0.001) 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 (16.8% versus 6.4%), whereas related non-ocular AEs were more frequent with TIM compared to FC (2.1% versus 0.0%). In the PS, AEs were similarly distributed between FC and TAF. The frequency of conjunctival hyperemia of FC was low (6.4%). 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. Santen Oy, Tampere, Finland.

Andreas Katsanos - One of the best experts on this subject based on the ideXlab platform.

  • preservative free Tafluprost timolol fixed combination comparative 24 h efficacy administered morning or evening in open angle glaucoma patients
    Expert Opinion on Pharmacotherapy, 2018
    Co-Authors: Anastasiosgeorgios Konstas, Andreas Katsanos, Irini C Voudouragkaki, Eirini Pagkalidou, Annabettina Haidich, Georgios P Athanasopoulos, Evangelia S Panagiotou, Dimitrios A Giannoulis, Eleni Spathi, Theodoros Giannopoulos
    Abstract:

    Ideal dosing for the preservative-free (PF) Tafluprost/timolol fixed combination (TTFC) remains to be elucidated. This study was a prospective, observer-masked, placebo-controlled, crossover, compa...

  • 24 hour efficacy and ocular surface health with preservative free Tafluprost alone and in conjunction with preservative free dorzolamide timolol fixed combination in open angle glaucoma patients insufficiently controlled with preserved latanoprost mo
    Advances in Therapy, 2017
    Co-Authors: Anastasiosgeorgios Konstas, Konstadinos G Boboridis, Paraskevas V Kapis, Konstantinos Marinopoulos, Irini C Voudouragkaki, Dimitrios Panayiotou, Dimitrios G Mikropoulos, Eirini Pagkalidou, Annabettina Haidich, Andreas Katsanos
    Abstract:

    The aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) Tafluprost and a PF triple drug regimen comprising Tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD). Prospective, observer-masked, crossover, comparison. Eligible consecutive open-angle glaucoma patients were randomized to either PF Tafluprost or the triple PF regimen for 3 months. They were then crossed over to the opposite therapy for another 3 months. At the end of the latanoprost run-in period and after each PF treatment period, patients underwent habitual 24-h intraocular pressure (IOP) monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00, and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00). Tolerability and selected ocular surface parameters were evaluated at baseline and the end of each treatment period. Forty-three open-angle glaucoma patients completed the trial. Mean 24-h IOP on preserved latanoprost was 22.2 ± 3.9 mmHg. Compared with latanoprost monotherapy, PF Tafluprost obtained a greater reduction in mean, peak, and fluctuation of 24-h IOP including the 02:00 and 06:00 time points (P < 0.05). With the exception of 24-h fluctuation, the triple PF regimen provided significantly lower IOP parameters than latanoprost or PF Tafluprost (P < 0.001). Finally, PF Tafluprost therapy displayed significantly improved tear film break-up times (6.7 vs 6.0 s), corneal staining (1.3 vs 2.2), and Schirmer I test results (9.1 vs 8.2 mm) compared with the preserved latanoprost baseline (all P < 0.01). The triple PF regimen demonstrated similar tear film break-up times (6.1 vs 6.0 s) and Schirmer I test results (8.2 vs 8.2 mm) to latanoprost, but revealed a significant improvement in the corneal stain test (1.7 vs 2.2; P < 0.001). In this trial PF Tafluprost therapy provided statistically greater 24-h efficacy and improved tolerability compared with preserved latanoprost. The combination of PF Tafluprost and PF dorzolamide/timolol fixed combination was statistically and clinically more efficacious than both monotherapies and demonstrated similar ocular surface characteristics to preserved latanoprost monotherapy. ClinicalTrials.gov (NCT02802137). Santen.

  • 24 hour efficacy and ocular surface health with preservative free Tafluprost alone and in conjunction with preservative free dorzolamide timolol fixed combination in open angle glaucoma patients insufficiently controlled with preserved latanoprost mo
    Advances in Therapy, 2017
    Co-Authors: Anastasiosgeorgios Konstas, Konstadinos G Boboridis, Paraskevas V Kapis, Konstantinos Marinopoulos, Irini C Voudouragkaki, Dimitrios Panayiotou, Dimitrios G Mikropoulos, Eirini Pagkalidou, Annabettina Haidich, Andreas Katsanos
    Abstract:

    Introduction The aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) Tafluprost and a PF triple drug regimen comprising Tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD).

  • safety and tolerability of the Tafluprost timolol fixed combination for the treatment of glaucoma
    Expert Opinion on Drug Safety, 2015
    Co-Authors: Gabor Hollo, Andreas Katsanos
    Abstract:

    Introduction: The preservative-free (PF) fixed combination (FC) of Tafluprost 0.0015%/timolol 0.5% is the newest member of the prostaglandin analogue/timolol FC class.Areas covered: In this review, we summarize data on safety and tolerability of this FC.Expert opinion: The intraocular pressure-lowering effect of the Tafluprost/timolol FC is approximately 30 – 35%, which is similar to that of the other members of the class. However, in contrast to most similar eye drops the Tafluprost/timolol FC is manufactured in a PF, unit-dose pipette formulation. The PF nature eliminates preservative-related ocular surface changes, and improves tolerability. In clinical studies, the Tafluprost/timolol FC was well tolerated. The side effects represented the typical side effects of the topical prostaglandin analogue class. The most common side effect, conjunctival hyperemia was mild, and occurred in only 6.4 – 8% of patients during 6 months of treatment. The figures for ocular irritation were also low (7.0 – 12.7%). The ...

  • twenty four hour efficacy with preservative free Tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension
    British Journal of Ophthalmology, 2013
    Co-Authors: Anastasiosgeorgios Konstas, James C Tsai, Andreas Katsanos, Irini C Voudouragkaki, Luciano Quaranta, Ivano Riva, Theodoros Giannopoulos, Eleni Paschalinou, Irene Floriani, Annabettina Haidich
    Abstract:

    AIM: To compare 24 h intraocular pressure (IOP) control obtained with preservative free (PF) Tafluprost 0.0015% versus branded preservative containing latanoprost 0.005% administered as first choice monotherapy in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT). METHODS: This prospective, observer-masked, crossover study included consecutive newly diagnosed patients with POAG or OHT, and baseline IOP between 24 and 33 mm Hg. Qualifying patients underwent baseline untreated 24 h IOP monitoring in habitual positions, with Goldmann tonometry at times 10:00, 14:00, 18:00 and 22:00, and Perkins supine tonometry at times 02:00 and 06:00. They were then randomised to either latanoprost or Tafluprost, administered in the evening, for 3 months and then switched to the opposite therapy for another 3 months. 24 h monitoring was repeated at the end of each treatment period. RESULTS: 38 patients completed the study. Mean untreated 24 h IOP (24.9 mm Hg) was significantly reduced with both prostaglandins (p<0.001). Tafluprost demonstrated similar mean 24 h efficacy compared with latanoprost (17.8 vs 17.7 mm Hg; p=0.417). Latanoprost demonstrated significantly better 24 h trough IOP (15.9 vs 16.3 mm Hg; p=0.041) whereas Tafluprost provided significantly lower 24 h IOP fluctuation (3.2 vs 3.8 mm Hg; p=0.008). No significant difference existed between the two prostaglandins for any adverse event. CONCLUSIONS: PF Tafluprost achieved similar 24 h IOP reduction to branded latanoprost. The current study highlights the importance of complete assessment of efficacy over 24 h. CLINICAL TRIALS REGISTRATION: NCT01162603.

Anastasiosgeorgios Konstas - One of the best experts on this subject based on the ideXlab platform.

  • preservative free Tafluprost timolol fixed combination comparative 24 h efficacy administered morning or evening in open angle glaucoma patients
    Expert Opinion on Pharmacotherapy, 2018
    Co-Authors: Anastasiosgeorgios Konstas, Andreas Katsanos, Irini C Voudouragkaki, Eirini Pagkalidou, Annabettina Haidich, Georgios P Athanasopoulos, Evangelia S Panagiotou, Dimitrios A Giannoulis, Eleni Spathi, Theodoros Giannopoulos
    Abstract:

    Ideal dosing for the preservative-free (PF) Tafluprost/timolol fixed combination (TTFC) remains to be elucidated. This study was a prospective, observer-masked, placebo-controlled, crossover, compa...

  • 24 hour efficacy and ocular surface health with preservative free Tafluprost alone and in conjunction with preservative free dorzolamide timolol fixed combination in open angle glaucoma patients insufficiently controlled with preserved latanoprost mo
    Advances in Therapy, 2017
    Co-Authors: Anastasiosgeorgios Konstas, Konstadinos G Boboridis, Paraskevas V Kapis, Konstantinos Marinopoulos, Irini C Voudouragkaki, Dimitrios Panayiotou, Dimitrios G Mikropoulos, Eirini Pagkalidou, Annabettina Haidich, Andreas Katsanos
    Abstract:

    The aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) Tafluprost and a PF triple drug regimen comprising Tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD). Prospective, observer-masked, crossover, comparison. Eligible consecutive open-angle glaucoma patients were randomized to either PF Tafluprost or the triple PF regimen for 3 months. They were then crossed over to the opposite therapy for another 3 months. At the end of the latanoprost run-in period and after each PF treatment period, patients underwent habitual 24-h intraocular pressure (IOP) monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00, and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00). Tolerability and selected ocular surface parameters were evaluated at baseline and the end of each treatment period. Forty-three open-angle glaucoma patients completed the trial. Mean 24-h IOP on preserved latanoprost was 22.2 ± 3.9 mmHg. Compared with latanoprost monotherapy, PF Tafluprost obtained a greater reduction in mean, peak, and fluctuation of 24-h IOP including the 02:00 and 06:00 time points (P < 0.05). With the exception of 24-h fluctuation, the triple PF regimen provided significantly lower IOP parameters than latanoprost or PF Tafluprost (P < 0.001). Finally, PF Tafluprost therapy displayed significantly improved tear film break-up times (6.7 vs 6.0 s), corneal staining (1.3 vs 2.2), and Schirmer I test results (9.1 vs 8.2 mm) compared with the preserved latanoprost baseline (all P < 0.01). The triple PF regimen demonstrated similar tear film break-up times (6.1 vs 6.0 s) and Schirmer I test results (8.2 vs 8.2 mm) to latanoprost, but revealed a significant improvement in the corneal stain test (1.7 vs 2.2; P < 0.001). In this trial PF Tafluprost therapy provided statistically greater 24-h efficacy and improved tolerability compared with preserved latanoprost. The combination of PF Tafluprost and PF dorzolamide/timolol fixed combination was statistically and clinically more efficacious than both monotherapies and demonstrated similar ocular surface characteristics to preserved latanoprost monotherapy. ClinicalTrials.gov (NCT02802137). Santen.

  • 24 hour efficacy and ocular surface health with preservative free Tafluprost alone and in conjunction with preservative free dorzolamide timolol fixed combination in open angle glaucoma patients insufficiently controlled with preserved latanoprost mo
    Advances in Therapy, 2017
    Co-Authors: Anastasiosgeorgios Konstas, Konstadinos G Boboridis, Paraskevas V Kapis, Konstantinos Marinopoulos, Irini C Voudouragkaki, Dimitrios Panayiotou, Dimitrios G Mikropoulos, Eirini Pagkalidou, Annabettina Haidich, Andreas Katsanos
    Abstract:

    Introduction The aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) Tafluprost and a PF triple drug regimen comprising Tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD).

  • preservative free Tafluprost timolol fixed combination a new opportunity in the treatment of glaucoma
    Expert Opinion on Pharmacotherapy, 2016
    Co-Authors: Anastasiosgeorgios Konstas, Gabor Hollo
    Abstract:

    ABSTRACTIntroduction: Medical therapy of glaucoma aims to maintain the patient’s visual function and quality of life. This generally commences with monotherapy, but it is often difficult to reach the predetermined target pressure with this approach. Fixed combinations (FCs) are therefore selected as the next step of the medical therapy algorithm. By employing a prostaglandin/timolol fixed combination (PTFC) the desired target 24-hour intraocular pressure can be reached in many glaucoma patients with the convenience of once-a-day administration and the associated high rate of adherence.Areas covered: The current role and value of FCs in the medical therapy of glaucoma is critically appraised. Special attention is paid to the PTFCs and the emerging role of preservative-free PTFCs. This review summarizes existing information on the efficacy and tolerability of the new preservative-free Tafluprost/timolol FC (Taptiqom®).Expert opinion: The preservative-free Tafluprost/timolol FC represents a promising stepwis...

  • twenty four hour efficacy with preservative free Tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension
    British Journal of Ophthalmology, 2013
    Co-Authors: Anastasiosgeorgios Konstas, James C Tsai, Andreas Katsanos, Irini C Voudouragkaki, Luciano Quaranta, Ivano Riva, Theodoros Giannopoulos, Eleni Paschalinou, Irene Floriani, Annabettina Haidich
    Abstract:

    AIM: To compare 24 h intraocular pressure (IOP) control obtained with preservative free (PF) Tafluprost 0.0015% versus branded preservative containing latanoprost 0.005% administered as first choice monotherapy in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT). METHODS: This prospective, observer-masked, crossover study included consecutive newly diagnosed patients with POAG or OHT, and baseline IOP between 24 and 33 mm Hg. Qualifying patients underwent baseline untreated 24 h IOP monitoring in habitual positions, with Goldmann tonometry at times 10:00, 14:00, 18:00 and 22:00, and Perkins supine tonometry at times 02:00 and 06:00. They were then randomised to either latanoprost or Tafluprost, administered in the evening, for 3 months and then switched to the opposite therapy for another 3 months. 24 h monitoring was repeated at the end of each treatment period. RESULTS: 38 patients completed the study. Mean untreated 24 h IOP (24.9 mm Hg) was significantly reduced with both prostaglandins (p<0.001). Tafluprost demonstrated similar mean 24 h efficacy compared with latanoprost (17.8 vs 17.7 mm Hg; p=0.417). Latanoprost demonstrated significantly better 24 h trough IOP (15.9 vs 16.3 mm Hg; p=0.041) whereas Tafluprost provided significantly lower 24 h IOP fluctuation (3.2 vs 3.8 mm Hg; p=0.008). No significant difference existed between the two prostaglandins for any adverse event. CONCLUSIONS: PF Tafluprost achieved similar 24 h IOP reduction to branded latanoprost. The current study highlights the importance of complete assessment of efficacy over 24 h. CLINICAL TRIALS REGISTRATION: NCT01162603.

Norbert Pfeiffer - One of the best experts on this subject based on the ideXlab platform.

  • preservative free fixed combination of Tafluprost 0 0015 and timolol 0 5 in patients with open angle glaucoma and ocular hypertension results of an open label observational study
    Clinical Ophthalmology, 2017
    Co-Authors: L E Pillunat, Auli Ropo, C Erb, F Kimmich, Norbert Pfeiffer
    Abstract:

    Background Efficacy, tolerability and safety of the novel preservative-free fixed combination of Tafluprost 0.0015%/timolol 0.5% (Taptiqom®) were investigated in an observational study in Germany. Objective To assess efficacy, tolerability and safety of the preservative-free fixed combination of Tafluprost 0.0015%/timolol 0.5% in a real-life setting. Methods Intraocular pressure (IOP) was recorded for each eye at baseline (any previous therapy or untreated) and 4-16 weeks after changing medical treatment to or initiating treatment with the preservative-free fixed combination of Tafluprost 0.0015%/timolol 0.5%. Change in IOP was evaluated over the study period for all patients and for specific pretreatment subgroups. Clinical signs such as conjunctival hyperemia and lid-parallel conjunctival folds (LIPCOF) were recorded using standardized comparative photographs. Corneal staining, subjective symptoms and local comfort were measured using a four-step scale. All adverse events were recorded. Results Among 1,157 patients enrolled, 1,075 patients were treated with the preservative-free fixed combination as the only medication at the final visit. Medical treatment was initiated in 741 patients because of an insufficient IOP-lowering effect of the prior medication. In 343 patients, medication was changed because of tolerability issues. The preservative-free fixed combination lowered IOP significantly in the subgroup of naive patients, all subgroups with prior monotherapy and patients with prior fixed combinations: naive patients: -8.9 mmHg, alpha- 2-agonists: -6.4 mmHg, beta-blockers: -5.7 mmHg, carbonic anhydrase inhibitors: -5.2 mmHg, prostaglandins: -4.7 mmHg, fixed-combination prostaglandins/timolol: -2.4 mmHg. At the final visit, clinical signs and subjective symptoms were improved in patients with prior medical therapy. Local comfort was rated as "very good" or "good" by 89.1% of patients at the final visit. Only few adverse events occurred during the treatment period. Conclusion The preservative-free fixed combination of Tafluprost 0.0015%/timolol 0.5% was effective, well tolerated and showed a good safety profile.

  • 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
    Advances in Therapy, 2014
    Co-Authors: Norbert Pfeiffer, Hannu Uusitalo, Carlo Enrico Traverso, Katrin Lorenz, Ville Saarela, Johanna Liinamaa, Yury S Astakhov, Ernest V Boiko, Auli Ropo
    Abstract:

    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. 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 ≥22 mmHg when on timolol (TIM) or of ≥20 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. 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 −8.55 mmHg (32%) for FC and −7.35 mmHg (28%) for TIM. The model-based treatment difference (FC–TIM) was −0.885 mmHg [95% confidence interval (CI) −1.745 to −0.024; 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 −8.61 mmHg (33%) for FC and −7.23 mmHg (28%) for TAF. The model-based treatment difference (FC–TAF) was −1.516 mmHg (95% CI −2.044 to −0.988; p < 0.001) 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 (16.8% versus 6.4%), whereas related non-ocular AEs were more frequent with TIM compared to FC (2.1% versus 0.0%). In the PS, AEs were similarly distributed between FC and TAF. The frequency of conjunctival hyperemia of FC was low (6.4%). 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. Santen Oy, Tampere, Finland.

  • efficacy and safety of Tafluprost 0 0015 and timolol maleate 0 5 fixed combination in patients with ocular hypertension or open angle glaucoma
    Expert Opinion on Pharmacotherapy, 2014
    Co-Authors: Katrin Lorenz, Norbert Pfeiffer
    Abstract:

    Introduction: Lowering intraocular pressure (IOP) is at present the only therapeutic approach to the treatment of glaucoma proven to be successful. The choice of therapy must take into account efficacy, tolerability, safety, quality of life, adherence and cost. Monotherapy fails to achieve a satisfactory IOP reduction in 40 – 75% of glaucoma patients after > 2 years of therapy. So far, three prostaglandin/timolol maleate 0.5% fixed combinations (FCs) are available.Areas covered: This review provides a background on the Tafluprost–timolol FC (TTFC, Santen Oy) and its individual compounds. It summarizes the data on efficacy and safety, including comparative data with prostaglandin/timolol FCs already available.Expert opinion: Tafluprost is a preservative-free prostaglandin analog with a similar IOP efficacy when compared with other prostaglandin analogs. However, its improved adverse effect profile seems to be beneficial in patients sensitive to preservatives. The preservative-free TTFC has no market author...

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  • preservative free Tafluprost timolol fixed combination comparative 24 h efficacy administered morning or evening in open angle glaucoma patients
    Expert Opinion on Pharmacotherapy, 2018
    Co-Authors: Anastasiosgeorgios Konstas, Andreas Katsanos, Irini C Voudouragkaki, Eirini Pagkalidou, Annabettina Haidich, Georgios P Athanasopoulos, Evangelia S Panagiotou, Dimitrios A Giannoulis, Eleni Spathi, Theodoros Giannopoulos
    Abstract:

    Ideal dosing for the preservative-free (PF) Tafluprost/timolol fixed combination (TTFC) remains to be elucidated. This study was a prospective, observer-masked, placebo-controlled, crossover, compa...

  • 24 hour efficacy and ocular surface health with preservative free Tafluprost alone and in conjunction with preservative free dorzolamide timolol fixed combination in open angle glaucoma patients insufficiently controlled with preserved latanoprost mo
    Advances in Therapy, 2017
    Co-Authors: Anastasiosgeorgios Konstas, Konstadinos G Boboridis, Paraskevas V Kapis, Konstantinos Marinopoulos, Irini C Voudouragkaki, Dimitrios Panayiotou, Dimitrios G Mikropoulos, Eirini Pagkalidou, Annabettina Haidich, Andreas Katsanos
    Abstract:

    The aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) Tafluprost and a PF triple drug regimen comprising Tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD). Prospective, observer-masked, crossover, comparison. Eligible consecutive open-angle glaucoma patients were randomized to either PF Tafluprost or the triple PF regimen for 3 months. They were then crossed over to the opposite therapy for another 3 months. At the end of the latanoprost run-in period and after each PF treatment period, patients underwent habitual 24-h intraocular pressure (IOP) monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00, and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00). Tolerability and selected ocular surface parameters were evaluated at baseline and the end of each treatment period. Forty-three open-angle glaucoma patients completed the trial. Mean 24-h IOP on preserved latanoprost was 22.2 ± 3.9 mmHg. Compared with latanoprost monotherapy, PF Tafluprost obtained a greater reduction in mean, peak, and fluctuation of 24-h IOP including the 02:00 and 06:00 time points (P < 0.05). With the exception of 24-h fluctuation, the triple PF regimen provided significantly lower IOP parameters than latanoprost or PF Tafluprost (P < 0.001). Finally, PF Tafluprost therapy displayed significantly improved tear film break-up times (6.7 vs 6.0 s), corneal staining (1.3 vs 2.2), and Schirmer I test results (9.1 vs 8.2 mm) compared with the preserved latanoprost baseline (all P < 0.01). The triple PF regimen demonstrated similar tear film break-up times (6.1 vs 6.0 s) and Schirmer I test results (8.2 vs 8.2 mm) to latanoprost, but revealed a significant improvement in the corneal stain test (1.7 vs 2.2; P < 0.001). In this trial PF Tafluprost therapy provided statistically greater 24-h efficacy and improved tolerability compared with preserved latanoprost. The combination of PF Tafluprost and PF dorzolamide/timolol fixed combination was statistically and clinically more efficacious than both monotherapies and demonstrated similar ocular surface characteristics to preserved latanoprost monotherapy. ClinicalTrials.gov (NCT02802137). Santen.

  • 24 hour efficacy and ocular surface health with preservative free Tafluprost alone and in conjunction with preservative free dorzolamide timolol fixed combination in open angle glaucoma patients insufficiently controlled with preserved latanoprost mo
    Advances in Therapy, 2017
    Co-Authors: Anastasiosgeorgios Konstas, Konstadinos G Boboridis, Paraskevas V Kapis, Konstantinos Marinopoulos, Irini C Voudouragkaki, Dimitrios Panayiotou, Dimitrios G Mikropoulos, Eirini Pagkalidou, Annabettina Haidich, Andreas Katsanos
    Abstract:

    Introduction The aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) Tafluprost and a PF triple drug regimen comprising Tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD).

  • twenty four hour efficacy with preservative free Tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension
    British Journal of Ophthalmology, 2013
    Co-Authors: Anastasiosgeorgios Konstas, James C Tsai, Andreas Katsanos, Irini C Voudouragkaki, Luciano Quaranta, Ivano Riva, Theodoros Giannopoulos, Eleni Paschalinou, Irene Floriani, Annabettina Haidich
    Abstract:

    AIM: To compare 24 h intraocular pressure (IOP) control obtained with preservative free (PF) Tafluprost 0.0015% versus branded preservative containing latanoprost 0.005% administered as first choice monotherapy in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT). METHODS: This prospective, observer-masked, crossover study included consecutive newly diagnosed patients with POAG or OHT, and baseline IOP between 24 and 33 mm Hg. Qualifying patients underwent baseline untreated 24 h IOP monitoring in habitual positions, with Goldmann tonometry at times 10:00, 14:00, 18:00 and 22:00, and Perkins supine tonometry at times 02:00 and 06:00. They were then randomised to either latanoprost or Tafluprost, administered in the evening, for 3 months and then switched to the opposite therapy for another 3 months. 24 h monitoring was repeated at the end of each treatment period. RESULTS: 38 patients completed the study. Mean untreated 24 h IOP (24.9 mm Hg) was significantly reduced with both prostaglandins (p<0.001). Tafluprost demonstrated similar mean 24 h efficacy compared with latanoprost (17.8 vs 17.7 mm Hg; p=0.417). Latanoprost demonstrated significantly better 24 h trough IOP (15.9 vs 16.3 mm Hg; p=0.041) whereas Tafluprost provided significantly lower 24 h IOP fluctuation (3.2 vs 3.8 mm Hg; p=0.008). No significant difference existed between the two prostaglandins for any adverse event. CONCLUSIONS: PF Tafluprost achieved similar 24 h IOP reduction to branded latanoprost. The current study highlights the importance of complete assessment of efficacy over 24 h. CLINICAL TRIALS REGISTRATION: NCT01162603.

  • twenty four hour efficacy with preservative free Tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension
    British Journal of Ophthalmology, 2013
    Co-Authors: Anastasiosgeorgios Konstas, James C Tsai, Andreas Katsanos, Irini C Voudouragkaki, Luciano Quaranta, Ivano Riva, Theodoros Giannopoulos, Eleni Paschalinou, Irene Floriani, Annabettina Haidich
    Abstract:

    Aim To compare 24 h intraocular pressure (IOP) control obtained with preservative free (PF) Tafluprost 0.0015% versus branded preservative containing latanoprost 0.005% administered as first choice monotherapy in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT). Methods This prospective, observer-masked, crossover study included consecutive newly diagnosed patients with POAG or OHT, and baseline IOP between 24 and 33 mm Hg. Qualifying patients underwent baseline untreated 24 h IOP monitoring in habitual positions, with Goldmann tonometry at times 10:00, 14:00, 18:00 and 22:00, and Perkins supine tonometry at times 02:00 and 06:00. They were then randomised to either latanoprost or Tafluprost, administered in the evening, for 3 months and then switched to the opposite therapy for another 3 months. 24 h monitoring was repeated at the end of each treatment period. Results 38 patients completed the study. Mean untreated 24 h IOP (24.9 mm Hg) was significantly reduced with both prostaglandins (p Conclusions PF Tafluprost achieved similar 24 h IOP reduction to branded latanoprost. The current study highlights the importance of complete assessment of efficacy over 24 h. Clinical trials registration NCT01162603.