tafluprost and Glaucoma--Open-Angle

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.. 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®).. The preservative-free tafluprost/timolol FC represents a promising stepwise treatment option for those patients whose intraocular pressure is insufficiently controlled with available monotherapy options. This novel FC has the potential to substantially improve glaucoma management and through evolution of the current glaucoma treatment paradigm, to become a core therapeutic option in the future. Nonetheless, future research is needed to better delineate the therapeutic role of current and future preservative-free FCs in glaucoma therapy.

Topics: Antihypertensive Agents; Disease Management; Drug Combinations; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F; Quality of Life; Timolol

A once-daily preservative-free fixed combination ophthalmic solution containing tafluprost 0.0015 % and timolol 0.5 % (hereafter referred to as tafluprost/timolol) [Taptiqom(®)] has been developed to lower intraocular pressure (IOP) whilst avoiding damage to the ocular surface associated with preservatives such as benzalkonium chloride. Tafluprost/timolol is available in various EU countries for the reduction of IOP in adults with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with β-adrenergic receptor antagonists or prostaglandin analogues and require a combination therapy, and who would benefit from preservative-free eye drops. In two multinational, phase III studies, tafluprost/timolol was superior to monotherapy with either preservative-free tafluprost 0.0015 % once daily or preservative-free timolol 0.5 % twice daily, and noninferior to concomitant therapy with preservative-free tafluprost 0.0015 % once daily plus preservative-free timolol 0.5 % twice daily in lowering IOP in adults with open-angle glaucoma or ocular hypertension. Tafluprost/timolol was well tolerated in these studies, with a tolerability profile consistent with that of its individual components and with no new adverse reactions observed. Thus, preservative-free fixed combination tafluprost/timolol is an effective treatment option for the reduction of IOP in adults with open-angle glaucoma or ocular hypertension, providing a useful alternative for those patients who would benefit from preservative-free eye drops.

Topics: Adrenergic beta-Antagonists; Drug Combinations; Glaucoma, Open-Angle; Humans; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F; Timolol

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.. 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.. 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 authorization yet. Only one Phase III trial was published so far, but results are promising in terms of efficacy, tolerability and safety. It is likely that the TTFC will play a role in the treatment of open-angle glaucoma and ocular hypertension.

Topics: Antihypertensive Agents; Drug Combinations; Drug Evaluation; Drug-Related Side Effects and Adverse Reactions; Glaucoma; Glaucoma, Open-Angle; Humans; Ocular Hypertension; Prostaglandins F; Timolol

To systematically review the efficacy and tolerability of 4 prostaglandin analogues (PGAs) as first-line monotherapies for intraocular pressure (IOP) lowering in adult patients with primary open-angle glaucoma or ocular hypertension.. A literature search was performed in PubMed (1965-June 2013) and the Cochrane Library (1980-June 2013) using the search terms ocular hypertension, open-angle glaucoma, prostaglandin analogues, bimatoprost, latanoprost, tafluprost, and travoprost. Additional studies were searched from the reference lists of identified publications.. In all, 32 randomized controlled trials comparing between PGAs (bimatoprost 0.03%, latanoprost 0.005%, tafluprost 0.0015%, and travoprost 0.004%) or PGA with timolol were selected.. A network meta-analysis was conducted. Using timolol as reference, the relative risks (RRs) of achieving treatment success, defined as the proportion of patients achieving at least 30% IOP reduction, with 95% CIs, were as follows: bimatoprost, 1.59 (1.28-1.98); latanoprost, 1.32 (1.00-1.74); travoprost, 1.33 (1.03-1.72); and tafluprost, 1.10 (0.85-1.42). The mean IOP reductions after 1 month were 1.98 (1.50-2.47), 1.01 (0.55-1.46), 1.08 (0.59-1.57), and 0.46 (-0.41 to 1.33) mm Hg, respectively, and the results were sustained at 3 months. Bimatoprost was associated with the highest risk of developing hyperemia, whereas latanoprost had the lowest risk, with RRs (95% CI) of 4.66 (3.49-6.23) and 2.30 (1.76-3.00), respectively.. Bimatoprost achieved the highest efficacy in terms of IOP reduction, whereas latanoprost had the most favorable tolerability profile. This review serves to guide selection of the optimal PGA agent for individual patient care in clinical practice.

Topics: Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prostaglandins F; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Timolol; Travoprost

A new preservative-free fixed-dose combination of 0.0015% tafluprost, a prostaglandin F2α analog, and 0.5% timolol (TAF/TIM; Santen Oy, Tampere, Finland), a beta-adrenergic antagonist has recently been developed. The intraocular pressure (IOP) reduction with TAF/TIM in open-angle glaucoma and ocular hypertension is similar to that of other prostaglandin-timolol fixed-combination products. Patients with high IOP responded well to TAF/TIM with reductions of up to 40% (>13 mmHg) and beyond. Compared to previous controlled and double-masked clinical trials with DuoTrav(®) (Alcon, Fort Worth, USA) and Ganfort(®) (Allergan, Irvine, USA), TAF/TIM caused less superficial ocular side effects and less conjunctival hyperemia. Plausible explanations for the differences in side effects between the fixed-combination products are discussed.

Topics: Adrenergic beta-Antagonists; Amides; Cloprostenol; Double-Blind Method; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F; Randomized Controlled Trials as Topic; Timolol

Topics: Contraindications; Drug Therapy, Combination; Glaucoma, Open-Angle; Humans; Ocular Hypertension; Prostaglandins F

To review the pharmacology, pharmacokinetics, clinical trial data, efficacy data, and adverse effect incidence of tafluprost.. A literature search was completed using PubMed, Web of Science, and Google Scholar. Tafluprost was the primary search term. Articles published between January 2008 and April 2012 were included in this review. Additional limits placed on the searches were "human" and "English." Citations in which tafluprost appeared in the title were 36, 29, and more than 300 in PubMed, Web of Science, and Google Scholar, respectively.. Three clinical trials were included in this review. One trial enrolled more than 500 subjects in a randomized fashion. Another also enrolled more than 500 subjects, although the study design was not randomized. The third trial evaluated the effects of tafluprost on subjects who had recently discontinued use of latanoprost, another prostaglandin that is approved to treat glaucoma and ocular hypertension. The duration of all 3 trials was 12 weeks.. Tafluprost 0.0015% is the first topical prostaglandin approved by the Food and Drug Administration for treatment of open-angle glaucoma and ocular hypertension that does not contain the widely used preservative, benzalkonium chloride (BAK). Although some controversy surrounds the long-term safety of exposure to BAK, clinical trial data are inconclusive. Tafluprost, like other prostaglandin analogues, exerts its effects on prostaglandin F receptors to reduce intraocular pressure (IOP). Results from 1 trial demonstrated significant reductions in IOP when monotherapy was switched to tafluprost monotherapy. Reductions in IOP with tafluprost use were compared with those seen with use of timolol and latanoprost in 2 trials, and noninferiority was observed. Significant reductions in tear osmolarity were noted in subjects who changed from latanoprost, another prostaglandin analogue, to tafluprost therapy. Conjunctival hyperemia is the most common adverse effect seen in patients receiving drugs from this class. Many have also reported stinging, ocular pruritus, increased darkening or growth of eyelashes, and darkening of eyelids, as well as irreversible brown pigmentation of the iris.. Clinical trial data suggest that tafluprost is as efficacious as other agents used in the management of ocular hypertension and glaucoma. Its use may be especially advantageous in people with allergies, sensitivities to preservatives, or dry or sensitive eyes.

Topics: Glaucoma, Open-Angle; Humans; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F

The objective of this review is to evaluate the safety and efficacy of tafluprost, a fluoroprostaglandin receptor analog, for reduction of intraocular pressure in open angle glaucoma and ocular hypertension.. A search of published literature was performed on the PubMed database using the search term "tafluprost." The literature search identified 48 publications, including clinical and preclinical studies, from 2003 to 2011. From these ressults, articles available in the English language and in full text were selected and systematically reviewed by the authors.. Recent studies have shown that tafluprost is an effective IOP-lowering medication. Evidence based medicine also reveals that tafluprost is safe and well-tolerated. Preservative-free tafluprost is as potent as the preserved formulation, but with fewer and milder ocular surface side effects.. Since its introduction in 2008, initial studies have demonstrated that preserved and preservative-free tafluprost formulations have proven efficacy and safety in the treatment of glaucoma and ocular hypertension. Larger studies with longer follow-up are needed to assess long-term safety, efficacy, and tolerability compared with other prostaglandin analogs used for treating glaucoma.

Topics: Animals; Dose-Response Relationship, Drug; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Prostaglandins F

Glaucoma affects an increasing number of people worldwide and is the second leading cause of blindness. The aim of antiglaucoma therapy is to maintain a patient's visual function and quality of life. Prostaglandin analogues are first-line topical antiglaucoma therapy. They are effective at lowering intraocular pressure (IOP) and are generally well tolerated, with fewer systemic adverse events compared with the other classes. However, the use of prostaglandin analogues can be associated with ocular adverse effects, such as stinging/burning sensation, dry eyes, iris and periocular hyperpigmentation, and eye lash growth, which can affect patient compliance. Preservatives used in antiglaucoma preparations can have dose-dependent toxic effects, which contribute to adverse effects. The development of preservative-free preparations may reduce such adverse effects and therefore improve patient compliance. Tafluprost is a prostaglandin analogue in a preservative-free formulation that was recently approved for the reduction of elevated IOP in open-angle glaucoma and ocular hypertension.

Topics: Blindness; Glaucoma; Glaucoma, Open-Angle; Humans; Hypersensitivity; Latanoprost; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F; Prostaglandins F, Synthetic; Prostaglandins, Synthetic

Prostaglandin analogs (PGAs) are the first-line treatment for primary open-angle glaucoma (POAG) and ocular hypertension (OH). This study aimed to confirm the effectiveness and safety of Tapros® (0.0015% tafluprost eye drops) in Chinese patients with POAG and OH.. This phase IV, multicenter, non-comparative, prospective study enrolled patients with POAG and OH in China between 12/27/2017 and 04/15/2020. Patients who were treatment-naïve or untreated within one month (group A) or with unreached intraocular pressure (IOP) target after previous monotherapy of other PGAs (group B) or non-PGA IOP-lowering drugs (group C) were treated with 0.0015% tafluprost for three months. The IOP reduction, response rate, and safety were observed.. There were 165, 89, and 31 patients in groups A, B, and C, with baseline IOPs of 22.4 ± 4.7, 21.0 ± 3.5, and 22.5 ± 3.2 mmHg, respectively. The least-square means and percentages of IOP reduction at 3 months for groups A, B, and C were 4.7 (19.8%), 1.6 (6.1%), and 4.6 mmHg (20.3%), respectively. A significant reduction in IOP was observed at each visit compared with baseline (all P < 0.05). At the final visit, 57.0% of the participants in group A achieved an IOP reduction of ≥ 20%, while 40.4% and 77.4% in groups B and C achieved an IOP reduction of ≥ 10%. Fifty-eight treatment-related adverse events occurred in 46 participants (15.7%), of which the most common one was conjunctival hyperemia (34/293, 11.6%).. Tafluprost showed a sustained and significant effect with tolerable adverse events in Chinese patients with POAG and OH who were treatment-naïve or untreated within one month or received prior treatments with unsatisfying outcomes.

Topics: Antihypertensive Agents; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Marketing; Ocular Hypertension; Ocular Hypotension; Prospective Studies; Prostaglandins F; Prostaglandins, Synthetic; Treatment Outcome

To compare the efficacies of latanoprost 0.005%, travoprost 0.004%, and tafluprost 0.0015% in reducing diurnal intraocular pressure (IOP) fluctuations in patients with newly diagnosed primary open-angle glaucoma (POAG).. In this prospective randomized clinical trial, 60 patients who were newly diagnosed with POAG were divided into three equal groups. Patients were examined at presentation and at second and sixth weeks. Diurnal phasing of IOP was conducted using a calibrated Goldmann applanation tonometer. IOP measurements were recorded from 8:00 am to 9:00 am, from 3:00 pm to 4:00 pm, and from 7:00 pm to 8:00 pm.. The study groups were distributed similarly in terms of age and gender (. Latanoprost, travoprost, and tafluprost show a similar effectiveness in reducing the mean IOP and the diurnal IOP fluctuation in POAG. Importantly, the three drugs have comparable tolerability with insignificant differences regarding the pattern of their side effects.

Topics: Adult; Aged; Antihypertensive Agents; Cloprostenol; Double-Blind Method; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Middle Aged; Ophthalmic Solutions; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Travoprost; Treatment Outcome

To compare the efficacy and the tolerability of preservative-free Tafluprost 0.0015% (TP) vs Latanoprost 0.005% (LP) in patients with primary open-angle glaucoma (POAG).. Prospective, randomized, crossover study included patients with early POAG attending the outpatient clinic from July 2019 to February 2020. Patients were divided into 2 groups: group A included patients receiving TP and group B receiving LP. After 2 months, treatment was stopped for 1 month (washout period) then drops were switched between the groups for further 2 months. Intraocular pressure (IOP) was recorded at baseline and monthly until 5 months. Efficacy was measured by the IOP reduction at the end of each treatment period. Tolerability was assessed both subjectively (questionnaire on ocular comfort) and objectively (ocular findings) at the end of each period.. A total of 30 patients were allocated into two groups (15 patients each). There was no statistically significant difference between the 2 groups in baseline clinical examinations. All the eyes in both groups achieved IOP reduction >20% compared to baseline values, with no statistically significant difference in between. Corneal erosions and conjunctival hyperemia were significantly higher in LP-treated eyes throughout the study, regardless of the sequence. Tear break-up time scores significantly worsened after LP at the 2. : Tafluprost was proved to exhibit a comparable effect on IOP control in POAG patients, as Latanoprost drops resulted in marked alleviation in both subjective and objective ocular discomfort manifestations.

Topics: Antihypertensive Agents; Cross-Over Studies; Glaucoma, Open-Angle; Humans; Latanoprost; Ocular Hypertension; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Treatment Outcome

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.. This was a 12-week, open-label, phase IV study.. Sixteen centres in Finland, Germany, Italy and the UK.. 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.. Patients were switched to PF tafluprost-timolol once daily in the treated eye(s).. 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.. 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<0.001). The percentage of patients with ocular signs and symptoms was significantly reduced at week 12 compared with screening (p<0.001). IOP was not affected by the change of treatment.. 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.. EudraCT2014-005273-37; Results.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Bimatoprost; Drug Administration Schedule; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intention to Treat Analysis; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins F; Quality of Life; Timolol

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.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Cross-Over Studies; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Sulfonamides; Thiophenes; Timolol; Tonometry, Ocular; Treatment Outcome

The aim of this study was to evaluate the efficacy and safety of preservative-free (PF) tafluprost compared with PF timolol in Indian subjects with open-angle glaucoma (OAG) or ocular hypertension.. This was a randomised, multicentre, double-masked, phase III trial. Subjects aged 18-80 years, following washout of current medication, with intraocular pressure (IOP) ≥ 24 and ≤ 36 mmHg in at least one eye were randomised in a 1:1 ratio to 0.0015% PF tafluprost or 0.5% PF timolol for 4 weeks. IOP was measured at 08:00, 10:00 and 16:00 hours at baseline and at weeks 2 and 4. The primary efficacy end-point was the mean diurnal IOP change from baseline at week 4, and PF tafluprost was considered non-inferior to PF timolol if the upper bound of the 95% confidence interval (CI) for between-treatment differences was ≤ 1.5 mmHg. The secondary end-point was the proportion of subjects with ≥ 25% reduction in IOP from baseline at week 4.. In total, 190 subjects were randomised, 95 each, to PF tafluprost and PF timolol treatment. PF tafluprost was non-inferior to PF timolol with respect to diurnal IOP changes from baseline over 4 weeks. The mean PF tafluprost-PF timolol difference in the diurnal IOP change was -1.7 (95% CI -2.6 to -0.7), suggestive of superiority for PF tafluprost. The secondary end-point was achieved in a higher proportion of PF tafluprost group subjects. Both PF tafluprost and PF timolol were well-tolerated with similar incidences of adverse events.. PF tafluprost was safe and efficacious in reducing IOP in Indian subjects.

Topics: Antihypertensive Agents; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; India; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prostaglandins F; Prostaglandins, Synthetic; Timolol

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.

Topics: Aged; Antihypertensive Agents; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Male; Middle Aged; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Timolol; Treatment Outcome

To evaluate some clinically important features of benzalkonium chloride (BAK) toxicity by comparing tafluprost with 0.001% BAK and travoprost preserved with SofZia applied to the ocular surface of the eyes with glaucoma.. This was a prospective, randomized, observer unmasked, multicenter crossover trial. A total of 195 patients were randomized and 174 patients completed the study at 19 clinics between November 2011 and August 2012. Topical BAK-preserved tafluprost or SofZia-preserved travoprost was newly administered or continued. Superficial punctate keratopathy (SPK), tear break-up time (BUT), the conjunctival hyperemia score, and intraocular pressure (IOP) were compared at the baseline visit, 4, and 12 weeks after the start of therapy. The eye drops were switched to another eye drop after 12 weeks of observation.. The total SPK and conjunctival hyperemia scores were significantly lower in the tafluprost compared with those in the travoprost phase (both P=0.038). There were no significant differences in the SPK scores of the superior area (P=0.679), central area (P=0.089), inferior area (P=0.090), and tear BUT (P=0.271). The IOP-lowering effects were similar (P=0.155).. SPK, hyperemia score, and tear BUT while using tafluprost with 0.001% BAK were not inferior compared with those caused by travoprost with SofZia.

Topics: Aged; Antihypertensive Agents; Benzalkonium Compounds; Cross-Over Studies; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Travoprost

To confirm the non-inferiority of the IOP-lowering effect of the 0.0015% Tafluprost ophthalmic solution to the 0.005% Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.Safety was also compared between two groups.. This study was conducted from August 2008 to December 2009, at five clinical trial sites in China. Patients of this study population was diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes.Subjects were randomized into 0.0015% Tafluprost group or 0.005% Latanoprost group.Intraocular pressure (IOP) measurement by Goldmann applanation tonometer, slit-lamp microscopy, Gonioscopy, Fundascopy, Visual acuity test, Perimetry, Blood pressure and pulse rate, Subjective symptoms were compered between two groups at Week 0, Week 2 and Week 4.For main effectiveness evaluation index adopt the bad effect evaluation, safety evaluation index by Fisher's exact test probability method.. The 246 subjects/246 eyes were randomized (Tafluprost group:122 subjects/122 eyes, Latanoprost group:124 subjects/ 124 eyes). Change in the IOP at 17:00 of Week 2 is (8.8 ± 3.8) mmHg and (8.9 ± 4.4) mmHg (1 mmHg = 0.133 kPa) in Tafluprost group and Latanoprost group. Percent change in the IOP at 17:00 of Week 2 is (33.2 ± 12.8)% and (34.4 ± 14.1)% in Tafluprost group and Latanoprost group. Change in the IOP at 17:00 at the end of treatment is (9.8 ± 4.0) mmHg and (9.2 ± 4.1) mmHg in Tafluprost group and Latanoprost group. Percent change in the IOP at 17:00 at the end of treatment is 37.2% ± 13.4% group and 35.7% ± 13.0% in Tafluprost and Latanoprost group.In addition, distribution of subjects with percentage decrease of IOP > 30% was 72.5% in Tafluprost group higher than 63.8% in Latanoprost group. The major adverse reactions were conjunctival hyperemia, eye irritation, eye pain and foreign body sensation. The incidence of adverse reactions is 31.7% in Tafluprost group and 20.8% in Latanoprost group. The inter-group difference had no statistical significance.. Efficacy and safety of Tafluprost ophthalmic solution are no less than Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Topics: Antihypertensive Agents; Blood Pressure; China; Conjunctival Diseases; Double-Blind Method; Eye; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F; Prostaglandins F, Synthetic; Tonometry, Ocular; Treatment Outcome; Visual Field Tests

A prospective study was performed to compare the ocular pulse amplitude (OPA)-lowering effects of tafluprost and latanoprost, used in the treatment of glaucoma, using dynamic contour tonometry.. The study population consisted of patients with normal-tension glaucoma (NTG) (n = 27) or primary open-angle glaucoma (POAG) (n = 14) treated with tafluprost and latanoprost. All patients were newly diagnosed with NTG and POAG and had undergone no previous treatment. Intraocular pressure (IOP) was measured by Goldmann applanation tonometry (GAT), OPA was measured by dynamic contour tonometry, and corrected OPA (cOPA) was calculated before and after 1 week, 1-3 months of treatment.. Initial IOP and OPA were 17.12 ± 3.75, 2.30 ± 0.56 mmHg and 17.53 ± 2.87, 2.65 ± 0.94 mmHg in the tafluprost and latanoprost groups, respectively. After 3 months of treatment, IOP and OPA were 13.00 ± 2.04 mmHg (24.1%) and 1.51 ± 0.30 mmHg (34.3%), respectively, in the tafluprost group. These values were 15.40 ± 2.32 mmHg (12.2%) and 2.08 ± 0.83 mmHg (21.5%), respectively, in the latanoprost group. Therefore, tafluprost significantly reduced IOP (P = 0.01), but OPA-lowering effects did not differ significantly between the 2 groups (P = 0.17). However, the cOPA-lowering effect of tafluprost (1.27 mmHg, 55.2%) was significantly greater than that of latanoprost (0.84 mmHg, 31.7%) after 3 months of treatment (P < 0.001).. Tafluprost and latanoprost, used to treat glaucoma, have marked OPA-lowering effects as well as IOP-lowering effects. Moreover, tafluprost has a greater effect than latanoprost. Therefore, it can be used for patients in need of IOP reduction and at risk of glaucoma progression.

Topics: Adult; Aged; Antihypertensive Agents; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Low Tension Glaucoma; Male; Middle Aged; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Tonometry, Ocular; Treatment Outcome

To compare efficacy, safety, and tolerability of the preservative-free fixed combination (FC) and non-fixed combination (NFC) of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension.. This 6-month, prospective, randomized, double-masked, active-controlled, parallel group, multicenter phase III study was performed in patients with ocular hypertension and open-angle glaucoma with untreated intraocular pressure (IOP) ≥23 and ≤36 mmHg at baseline.. Four hundred patients washed out from IOP-lowering medication were randomized, 201 received the FC, and 199 received the NFC. Mean time-wise IOP decreases from baseline ranged from -7.3 to -9.1 mmHg (29.6%-34.6%) in the FC and from -7.5 to -9.4 mmHg (30.7%-36.0%) in the NFC arm [per-protocol (PP) dataset, P<0.0001 compared with baseline for both groups]. At month 6, the estimated overall treatment difference (FC-NFC) was 0.308 mmHg (PP dataset, 95% confidence interval from -0.194 to 0.810 mmHg). An IOP decrease ≥30% was achieved in 58.3% and 66.9% of the patients in the FC and NFC groups, respectively (PP dataset; P=0.105); an IOP decrease ≥35% was achieved in 36.6% and 43.1% of patients in the FC and NFC groups, respectively (PP dataset; P=0.297). Patients with ocular adverse events were evenly distributed in both groups. The most common side effect, conjunctival/ocular hyperemia was found in 8% and 5% of patients in the FC and NFC arms, respectively.. All measures of IOP reduction for FC of preservative-free tafluprost/timolol were statistically and clinically significant and non-inferior to those of the NFC, throughout the 6-month study period.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F; Timolol; Young Adult

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.

Topics: Adult; Antihypertensive Agents; Double-Blind Method; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F; Timolol; Tonometry, Ocular; Treatment Outcome

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).. 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.. 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.. 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.. NCT01162603.

Topics: Aged; Antihypertensive Agents; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Treatment Outcome

To evaluate the effect of tafluprost on the central corneal thickness (CCT) in patients with primary open-angle glaucoma (POAG).. This was a prospective study and included 100 eyes of 54 patients with POAG. All patients received tafluprost 0.0015% (Saflutan®) once daily in one or both eyes. CCT was measured by using noncontact pachymetry prior to the treatment and after 6 and 12 months.. Mean CCT of all treated eyes (n = 100) was 547.79 ± 29.48 μm at baseline, 535.61 ± 26.54 μm after 6 months and 533.55 ± 26.45 μm after 12 months (Student's t test, p < 0.0001). Ninety-three percent of all treated eyes showed a decrease of CCT. CCT reduction was more significant within the first six months of the treatment period (Student's t test, p < 0.0001). After 12 months, a CCT reduction >25 μm occurred in 5% of all treated eyes. There was a significant positive correlation between the magnitude of corneal thinning and the initial CCT (Pearson, r = 0.49, p < 0.0001) but not between the magnitude of corneal thinning and intraocular pressure (IOP) reduction (Pearson, r = 0.145, p = 0.15).. Long-term use of tafluprost may decrease the CCT in patients with POAG. Consequently, clinicians must be aware of prolongated CCT variations that may arise throughout the follow-up period for proper IOP targeting and management.

Topics: Adult; Aged; Aged, 80 and over; Cornea; Dinoprost; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Prospective Studies; Prostaglandins F; Treatment Outcome

To compare the efficacy and safety of tafluprost, a preservative-free (PF) prostaglandin analogue, with PF timolol in patients with open-angle glaucoma or ocular hypertension.. Randomized, double-masked, multicenter clinical trial.. After discontinuation and washout of existing ocular hypotensive treatment, patients who had intraocular pressure (IOP) ≥23 and ≤36 mm Hg in at least 1 eye at the 08:00 hour time point were randomized 1:1 to 12 weeks of treatment with either PF tafluprost 0.0015% or PF timolol 0.5%. IOP was measured 3 times during the day (08:00, 10:00, 16:00 hours) at baseline and at weeks 2, 6, and 12. It was hypothesized that PF tafluprost would be noninferior to PF timolol over 12 weeks with regard to change from baseline IOP. The trial was powered for a noninferiority margin of 1.5 mm Hg at each of the 9 time points assessed.. A total of 643 patients were randomized and 618 completed (PF tafluprost = 306, PF timolol = 312). IOPs at the 3 time points assessed during the baseline visit ranged from 23.8 to 26.1 mm Hg in the PF tafluprost group and 23.5 to 26.0 mm Hg in the PF timolol group. IOPs at the 3 time points assessed during the 12-week visit ranged from 17.4 to 18.6 mm Hg for PF tafluprost and 17.9 to 18.5 mm Hg for PF timolol. At all 9 time points, the upper limits of the 2-sided 95% confidence intervals for the difference between treatments in IOP lowering were less than the prespecified noninferiority margin. Similar percentages of PF tafluprost and PF timolol patients reported ocular pain/stinging/irritation (4.4% vs 4.6%) and pruritus (2.5% vs 1.5%). The percentages of PF tafluprost and PF timolol patients reporting conjunctival hyperemia were 4.4% vs 1.2% (nominal P = .016).. The IOP-lowering effect of PF tafluprost was noninferior to that of PF timolol. PF tafluprost is an efficacious and generally well-tolerated ocular hypotensive agent.

Topics: Antihypertensive Agents; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins F; Timolol; Tonometry, Ocular; Treatment Outcome; Visual Acuity

To evaluate the ocular surface symptoms and signs associated with preservative-free 0.0015% tafluprost in patients with glaucoma or ocular hypertension (OHT).. Prospective non-interventional, multicentre, observational study on 134 patients, naive or on previous treatment with another prostaglandin analogue. In each visit (V1 baseline visit, V2 at 1 month and V3 at 3 months), patients evaluated five ocular surface symptoms as: absent, mild, moderate and severe. Parallelly, the ophthalmologist assessed the tear break-up time, keratitis, conjunctival hyperaemia, blepharitis, Schirmer test and tear meniscus.. Patients with OHT (n=71, 53%) experienced a statistically significant improvement of all symptoms: stinging/burning/irritation, itching, foreign body sensation, tearing and dryness sensation at V3, while glaucoma patients improved all symptoms at both V2 and V3. In patients with OHT, all signs except Schirmer test improved and the decrease in hyperaemia was statistically significant. Eyes with glaucoma ameliorated the keratitis, hyperaemia and tear meniscus at V2 and V3 and the break-up time and blepharitis at V3. In the subset of patients with previous treatment (n=79, 58.9%), patients with OHT presented significant improvement of hyperaemia, yet the rest of signs did not decrease significantly or remained unchanged, while in patients with glaucoma all signs improved significantly at both visits. The intraocular pressure (IOP) drop in naive eyes was 22.2% (24.7-19.7 mm Hg) in OHT and 29.5% (33.7-25.3 mm Hg) in glaucoma eyes. In previously treated eyes, no statistically significant change in IOP was found.. Preservative-free tafluprost is a well tolerated hypotensive agent that can be used in eyes with surface problems and in naive eyes.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Conjunctiva; Cornea; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Spain; Tonometry, Ocular

To compare the ocular hypotensive effect of tafluprost with prostaglandin analogues (PGAs) in glaucoma patients.. 89 primary open-angle glaucoma patients treated with bimatoprost, latanoprost, or travoprost for at least 3 months complaining for ocular discomfort were switched to tafluprost. IOP was assessed at baseline and 3 months after switching the therapy by daily curve. Primary outcome was to compare the mean daily IOP of tafluprost with PGAs.. The mean daily IOP was 16 ± 2.1 and 16.6 ± 2.0 mm Hg at baseline and after switching to tafluprost, respectively (P > 0.05). When analysis was carried out between tafluprost and each previous PGAs, the comparison between latanoprost and tafluprost and travoprost and tafluprost did not show any statistically significant difference in mean daily IOP and at each time point. The comparison between bimatoprost and tafluprost showed a statistically significant difference in mean daily IOP (P < 0.05) and at each time point (P < 0.05).. After 3 months of switching tafluprost showed an overall IOP lowering effect similar to others PGAs. When each PGA was compared with tafluprost, bimatoprost showed to provide a statistically significant additional IOP lowering effect.

Topics: Aged; Amides; Bimatoprost; Cloprostenol; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Middle Aged; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Time Factors; Travoprost; Treatment Outcome

Tafluprost is a novel prostaglandin F(2alpha)-receptor agonist shown to lower intraocular pressure (IOP) in healthy humans and patients with elevated IOP. We investigated the efficacy, safety, and tolerability of tafluprost 0.0015% compared with latanoprost 0.005% in patients with primary open-angle glaucoma, exfoliation glaucoma, or ocular hypertension.. This was a randomized, double-masked, active-controlled, parallel-group, multinational, and multicenter phase II study. Patients received either tafluprost 0.0015% (n = 19) or latanoprost 0.005% (n = 19), both once daily. The extent and duration of action of the IOP-lowering effects at Day 42 and Day 43 were the primary efficacy endpoints. Efficacy and safety parameters were analyzed throughout.. Maximum IOP reduction was achieved by Day 7 and was sustained until Day 42 in both groups (mean [standard deviation] change from baseline -9.7 [3.3] mm Hg for tafluprost and -8.8 [4.3] mm Hg for latanoprost). The overall treatment group difference was 0.17 mm Hg (95% confidence interval -1.27 to 1.61; P = 0.811). The IOP-lowering effect was maintained for >or=24 h after the last dose in both groups. Most adverse events were ocular and were similar in frequency and severity between groups. There were 3 severe adverse events, all ocular, and all in the tafluprost group (3/19 = 16%).. Tafluprost and latanoprost have comparable effects on the extent, duration, and stability of IOP reduction, and are well tolerated in patients.

Topics: Double-Blind Method; Exfoliation Syndrome; Eye; Female; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Ocular Hypertension; Prostaglandins F; Prostaglandins F, Synthetic; Time Factors; Treatment Outcome; Young Adult

The objective of the study was to compare the long-term efficacy and safety of tafluprost 0.0015% with latanoprost 0.005% eye drops in patients with open-angle glaucoma or ocular hypertension.. This double-masked, active-controlled, parallel-group, multinational, multicentre, phase III study was conducted at 49 centres in 8 countries. Eligible patients were assigned to treatment administered once daily at 20:00 hrs for up to 24 months. Change from baseline intraocular pressure (IOP) was the primary efficacy variable. Adverse events were recorded and ocular safety was evaluated. Both tafluprost and latanoprost were preserved with benzalkonium chloride.. From 533 patients randomized, 402 patients completed 24 months of therapy. Both treatments had a substantial IOP-lowering effect which persisted throughout the study (-7.1 mmHg for tafluprost and -7.7 mmHg for latanoprost at 24 months). Although the IOP-lowering effect during the study was slightly larger with latanoprost, this difference was clinically small and the noninferiority of tafluprost to latanoprost over all diurnal IOP measurements was shown with anova and almost reached with ancova (upper limits of the 95% confidence intervals 1.38 and 1.52 for the overall period, respectively). The noninferiority limit was 1.5 mmHg.. Tafluprost is a new effective and well-tolerated treatment for glaucoma and ocular hypertension.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Circadian Rhythm; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prostaglandins F; Prostaglandins F, Synthetic; Treatment Outcome; Young Adult

Tafluprost is a new prostaglandin F(2alpha) (PGF(2alpha)) derivative in development for the treatment of glaucoma. Tafluprost is the first PGF(2alpha) analogue with a preservative-free formulation.. This randomized, investigator-masked, multicentre, crossover phase III study evaluated the pharmacodynamics and safety of preserved and preservative-free tafluprost 0.0015% eyedrops administered for 4 weeks in 43 patients with open-angle glaucoma or ocular hypertension. The primary variable was change from baseline in overall diurnal intraocular pressure (IOP) at 4 weeks. Adverse events and other safety parameters were also analysed.. Decreased IOP was clearly observed with both formulations at week 1 and was sustained until week 4. The overall treatment difference (preservative-free versus preserved formulations) at week 4 was 0.01 mmHg (95% confidence interval - 0.46 to 0.49; p = 0.96). There were no unexpected safety-related findings. Both formulations were well tolerated and most adverse events were ocular and mild in severity.. THE reduction in IOP achieved by preservative-free tafluprost is equivalent to that obtained with the preserved formulation. The preservative-free formulation was generally well tolerated.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Cross-Over Studies; Double-Blind Method; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins F; Therapeutic Equivalency; Treatment Outcome

To investigate the intraocular pressure (IOP) lowering effect of topical preserved tafluprost 0.0015% in a tertiary hospital setting in India.. This is a retrospective chart review of patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) attending regular outpatient visits in December 2019 and January 2021, and treated with topical preserved tafluprost 0.0015%. Based on their medication history, patients were divided into two groups, the "treatment naïve" group and the "switched" group, which included patients switched to tafluprost monotherapy after treatment with at least one prior drug.. The mean IOP of the study population reduced significantly from baseline level by 20.6% and 25.5% at 1 month and 3 months after preserved tafluprost 0.0015% treatment (P < 0.001 for both). The mean IOP in patients with only OHT reduced significantly from baseline level by 21% and 26% at 1 month and 3 months after preserved tafluprost 0.0015% treatment (P < 0.001 for both). The mean IOP in patients with POAG reduced significantly from baseline level by 19% and 24% at 1 month and 3 months after preserved tafluprost 0.0015% treatment (P < 0.001 for both). The baseline IOP ± SD in POAG treatment naïve patients was 25.3 ± 0.3 mmHg, which reduced significantly by 24% and 28% at 1 month and 3 months after preserved tafluprost 0.0015% treatment (P < 0.001 for both). The baseline IOP ± SD in POAG switched patients was 24.3 ± 0.1 mmHg, which reduced significantly by 18% and 22% at 1 month and 3 months after preserved tafluprost 0.0015% treatment (P < 0.001 for both). In the POAG switch group, the percent reduction in IOP at 3 months after preserved tafluprost 0.0015% treatment was 23% with timolol as first line, 22% with bimatoprost as first line, 20% with latanoprost as first line, and 19% with travoprost as first line (P < 0.001 for all).. We show significant IOP reduction with preserved tafluprost 0.0015% in a real-world setting. As first-line monotherapy in patients with OHT and in POAG-naïve patients, preserved tafluprost 0.0015% significantly reduced IOP at 3 months. Even as second-line therapy in nonresponders (POAG-Switched) to various drugs (same class [PGAs] versus different class), treatment with preserved tafluprost 0.0015% resulted in significant IOP reduction at 3 months.

Topics: Antihypertensive Agents; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Prostaglandins F; Retrospective Studies; Timolol; Treatment Outcome

Treatment of open angle glaucoma (OAG) and/or ocular hypertension (OHT) focuses on achievement of target intraocular pressure (IOP), with the objective of slowing disease progression. However, ocular surface health is an important consideration in the optimization of treatment. We report 6 patient cases in which enhanced IOP control was achieved following appropriate management of ocular surface inflammation and a therapeutic switch to the preservative-free (PF) tafluprost (0.0015%)/timolol (0.5%) fixed-dose combination (FC).. Six patient cases, aged 48-74 years, presented with OAG or OHT. Each patient had signs and symptoms of ocular surface disease (OSD). Cases 1-3 were each receiving maximal medical therapy for OAG; regimens comprising prostaglandin analogue (PGA), β-blocker, carbonic anhydrase inhibitor (CAI) and α-2 agonist agents (including treatments containing preservative agent). Cases 1 and 2 reported IOP values ≥23 mmHg in each eye, and wide IOP fluctuations were identified when reviewing patient data concerning case 3 (11-20 mmHg). Maximal therapy was ceased and PF tafluprost/timolol FC was initiated, after which the signs and symptoms of OSD were improved and IOP was reduced (≤18 mmHg for cases 1-3) and stabilized. Cases 4 and 5 were diagnosed with OAG and case 6 had OHT. Each had symptoms and signs of OSD and were treated with a preserved PGA monotherapy (latanoprost 0.005% or bimatoprost 0.03%). At presentation, IOP was 24 mmHg in both eyes (case 4), ≥18 mmHg (case 5) and ≥ 22 mmHg (case 6). Following a switch to the PF tafluprost/timolol FC, OSD symptoms were improved and IOP was 14 mmHg (both eyes; case 4), ≤14 mmHg (case 5) and 16 mmHg (both eyes; case 6).. In addition to IOP-lowering efficacy, approaches to the management of OAG and OHT should consider the impact of treatment tolerability and the susceptibility of these patients to OSD. The presence of ocular surface inflammation appears to be detrimental to adherence and therefore to the effectiveness of topical medications. Addressing OSD through the use of PF FC formations, such as the PF tafluprost/timolol FC, reduces exposure to potentially toxic agents and facilitates improvements in IOP control.

Topics: Aged; Antihypertensive Agents; Glaucoma, Open-Angle; Humans; Middle Aged; Ocular Hypertension; Prostaglandins F; Timolol

The VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Current subanalyses have examined these data according to the baseline monotherapy.. A European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF-latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6.. The subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 (p < 0.001). Mean (SD) IOP change at Month 6 was 6.6 (4.16), 6.3 (4.39), 5.6 (3.67), 4.9 (2.97), 4.6 (4.39), and 4.7  (3.64) mmHg for prior beta-blocker, preserved latanoprost, PF-latanoprost, tafluprost, bimatoprost, and travoprost subgroups, respectively. The largest IOP change was observed in the preserved latanoprost subgroup for each of the ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% IOP reduction categories at Month 6, demonstrating respective reductions of 8.06, 9.20, 10.64, and 11.55 mmHg. CFS was significantly reduced at Month 6 in the prior bimatoprost subgroup (p = 0.0013). Conjunctival hyperemia severity was significantly reduced at each study visit for prior preserved latanoprost users (p < 0.001).. PF tafluprost/timolol FC therapy provided statistically and clinically significant IOP reductions from Week 4 over the total 6-month period, in patients with OAG/OHT, regardless of the type of prior PGA or beta-blocker monotherapy used. Conjunctival hyperemia severity and CFS decreased significantly in prior bimatoprost and preserved latanoprost users, respectively.. European Union electronic Register of Post-Authorization Studies (EU PAS) register number: EUPAS22204.

Topics: Adult; Antihypertensive Agents; Bimatoprost; Drug Combinations; Glaucoma; Glaucoma, Open-Angle; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Ocular Hypertension; Prospective Studies; Prostaglandins A; Prostaglandins F; Timolol; Travoprost

Analysis and comparison of country-level data from the VISIONARY study, examining treatment outcomes with the topical fixed-dose combination of preservative-free tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) who were insufficiently treated with or unable to tolerate either beta-blocker or prostaglandin analogue (PGA) topical monotherapy.. A European, prospective, observational study was conducted in 11 countries. Adults with OAG/OHT were switched to the PF tafluprost/timolol FC from either PGA or beta-blocker topical monotherapy. Statistical analysis examined changes in mean standard deviation (SD) intraocular pressure (IOP) from baseline at Week 4, Week 12 and Month 6. Data were documented for each eye separately at baseline and during follow up visits, with the eye reported to have the higher IOP (mmHg), as measured using Goldmann applanation tonometry, being selected for analysis (study eye). Country-level subanalysis examined outcomes by prior monotherapy, diagnosis and timing of dosing for those countries recruiting ≥20 patients (Country-level Subanalysis Population). Two-sided paired. Subanalysis of VISIONARY study data revealed significant IOP reductions following a switch to the PF tafluprost/timolol FC from either PGA or beta-blocker topical monotherapy. Cross-country variation was likely due to baseline IOP differences. Within country, outcomes were consistent regardless of diagnosis, dosing or prior monotherapy. Treatment was generally well tolerated.

Topics: Adrenergic beta-Antagonists; Adult; Antihypertensive Agents; Drug Combinations; Female; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins A; Prostaglandins F; Timolol; Treatment Outcome

Elevated intraocular pressure (IOP) is the most important modifiable risk factor for irreversible sight loss in open-angle glaucoma (OAG). The topical fixed-dose combination (FC) of preservative-free (PF) tafluprost (0.0015%) and timolol (0.5%) (tafluprost/timolol) is among the second-line IOP-lowering options for OAG and ocular hypertension (OHT).. PubMed searches identified publications reporting key evidence from randomized controlled trials (RCTs) and real-world studies examining the safety, tolerability, and IOP-lowering efficacy of PF tafluprost/timolol FC therapy in OAG/OHT management.. Glaucoma patients are more likely to have ocular surface disease, and treatment should be individualized so that target response may be achieved while considering tolerability and quality of life, according to European Glaucoma Society guidelines. PF FC therapies, such as PF tafluprost/timolol FC, avoid ocular surface exposure to toxic preservative agents and reduce the required number of treatment administrations. These properties may enhance treatment tolerability and adherence, resulting in improved IOP-lowering efficacy and disease control. Treatment outcomes from RCTs and real-world studies examining PF tafluprost/timolol FC therapy support this hypothesis, with significant IOP reductions and/or improvements in tolerability parameters demonstrated, regardless of the prior topical therapy used and even when switched directly to PF tafluprost/timolol FC treatment (without washout).

Topics: Antihypertensive Agents; Drug Combinations; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Preservatives, Pharmaceutical; Timolol

Reducing intraocular pressure (IOP), the only modifiable risk factor for open-angle glaucoma (OAG), is important for the preservation of vision and slowing of disease progression. Preservative-free tafluprost (0.0015%)/timolol (0.5%) fixed combination (PF Taf-T FC) is an approved combination therapy for OAG treatment. The VISIONARY study aimed to evaluate the effectiveness and tolerability of PF Taf-T FC in real-world clinical settings. Here, we present the results from the United Kingdom (UK) and Ireland.. This observational, multicentre, European, prospective study recorded data during routine clinic appointments on the use of PF Taf-T FC for the treatment of OAG and ocular hypertension (OHT) in patients whose disease was insufficiently controlled on a prostaglandin analogue (PGA) or beta blocker monotherapy or who did not tolerate these medications. Mean change in IOP, symptom severity, changes in clinical signs, and tolerability were investigated over 6 months.. Eighty-two patients were recruited in the UK and Ireland. After 6 months of PF Taf-T FC treatment, mean IOP was significantly reduced from 22.0 to 16.2 mmHg in the UK group and from 18.6 to 14.1 mmHg in the Ireland group. In the UK (65 patients), 49 adverse events (AEs) were reported, of which 3 were serious. No AEs were reported in the Ireland group (17 patients). Overall, 91.9% of UK physicians reported PF Taf-T FC treatment to be the same or better than prior medication for improving clinical signs; 90.0% of UK patients reported PF Taf-T FC treatment to have good or very good tolerability.. Treatment with PF Taf-T FC resulted in significant reductions in mean IOP over 6 months. Patients and physicians reported that treatment was well tolerated. These data demonstrate real-world efficacy of PF Taf-T FC for the treatment of OAG and OHT in routine clinical practice in the UK and Ireland.. European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.

Topics: Antihypertensive Agents; Drug Combinations; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ireland; Ocular Hypertension; Prospective Studies; Prostaglandins F; Timolol; United Kingdom

A non-interventional, multicenter, European, prospective evaluation of the effectiveness, tolerability, and safety of a topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) demonstrating insufficient response to topical beta-receptor blockers or prostaglandin analogue (PGA) monotherapy.. Mean intraocular pressure (IOP) change from baseline was measured at study visits following a switch to PF tafluprost/timolol FC. Primary endpoint was absolute mean IOP change at month 6. Change from baseline concerning ocular signs and symptoms was also explored.. Analyses included 577 patients (59.6% female). Mean age (SD) was 67.8 (11.67) years. Mean (SD) IOP reduction from baseline was significant at all study visits; 5.4 (3.76) mmHg (23.7%) at week 4, 5.9 (3.90) mmHg (25.6%) at week 12, and 5.7 (4.11) mmHg (24.9%) at month 6 (p < 0.0001 for all visits). At month 6, 69.2%, 53.6%, 40.0%, and 25.8% were responders based on ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% cutoff values for mean IOP, respectively. Significant reductions were observed concerning corneal fluorescein staining (p < 0.0001), dry eye symptoms, irritation, itching, and foreign body sensation (p < 0.001 for each parameter). Conjunctival hyperemia was significantly reduced at all study visits (p < 0.0001 at each visit). Overall, 69 treatment-related adverse events (AEs) were reported, one of which was serious (status asthmaticus). Most AEs were mild to moderate in severity, and the majority had resolved or were resolving at the end of the study period.. In clinical practice, PF tafluprost/timolol FC provided statistically and clinically significant IOP reductions in patients with OAG and OHT insufficiently controlled on or intolerant to PGA or beta-receptor blocker monotherapy. The full IOP reduction appeared at week 4 and was maintained over the 6-month study period. Key symptoms of ocular surface health improved.. European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Drug Combinations; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Prostaglandins, Synthetic; Timolol; Tonometry, Ocular

Primary open-angle glaucoma (POAG) is a progressive neurodegenerative disease which leads to irreversible blindness. An elevated intraocular pressure (IOP) is considered to be the main risk factor for the disease progression. It is known that retinal blood flow is altered in POAG eyes. Tafluprost, a prostaglandin analogue which lowers the IOP, has shown to also improve the retinal blood flow in animals.. The current study therefore evaluated the retinal vessel density in the peripapillary and macular region of POAG patients with normal IOP treated with topical Tafluprost (n = 20) compared to surgically treated patients with normal IOP (n = 22) using optical coherence tomography angiography (OCT-A). The retinal flow density was obtained after binarisation and evaluated in five sectors.. There was a significantly higher peripapillary flow density in all sectors in Tafluprost treated eyes when compared to post-surgery eyes. The flow density in the inferior sector of the superficial plexus in the macular region was also significantly higher in the Tafluprost group.. These results indicate that Tafluprost not only lowers IOP, but may also enhance retinal blood flow in POAG patients with a normal IOP.

Topics: Angiography; Animals; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Neurodegenerative Diseases; Optic Disk; Prostaglandins F; Retinal Vessels; Tomography, Optical Coherence

To perform patient preference-based comparative effectiveness and cost-utility (cost-effectiveness) analyses to evaluate topical bimatoprost 0.01%, latanoprost 0.005%, travoprost 0.004%, tafluprost 0.0015%, and timolol 0.5% for the treatment of open-angle glaucoma (OAG).. Value-Based Medicine. Bimatoprost conferred a mean 2.56 QALY gain (22.9% patient quality-of-life gain) for the average OAG patient, while latanoprost for the average OAG patient, while latanoprost conferred a 2.00 QALY gain (17.8% quality-of-life gain), tafluprost a 1.99 QALY gain (17.9% quality-of-life gain), travoprost a l.92 QALY gain (17.2% quality-of-life gain), and timolol a 1.42 QALY gain (12.8% quality-of-life gain). The ophthalmic cost-perspective, incremental cost-utility ratio of bimatoprost referent to travoprost was $6,034/QALY, to latanoprost was $27,973/QALY, and to timolol was $16,063/QALY. Bimatoprost dominated tafluprost, meaning that it conferred greater patient value for lesser cost than tafluprost.. Topical bimatoprost delivers greater patient value than the other prostamides and topical timolol for the treatment of OAG. Bimatoprost is incrementally cost-effective referent to the other prostamides and timolol.

Topics: Bimatoprost; Cost-Benefit Analysis; Glaucoma, Open-Angle; Health Care Costs; Humans; Intraocular Pressure; Latanoprost; Patient Preference; Prostaglandins F; Timolol; Travoprost; Visual Acuity

To compare the efficacy and safety of two combinations of maximum medical therapy for lowering intraocular pressure (IOP) in primary open angle glaucoma (POAG).. A retrospective consecutive case series.. A retrospective consecutive case series study including 82 eyes of 82 subjects with POAG treated with maximum medical therapy to lower IOP. Enrolled patients were divided into 2 groups: the triple maximum medical therapy (TMT) group, comprising POAG patients who were treated with tafluprost, brimonidine and the fixed drug combination (FDC) brinzolamide/timolol; and the double maximum medical therapy (DMT) group, comprising POAG patients who were treated with the FDCs tafluprost/timolol and brinzolamide/brimonidine. We compared the demographics, baseline IOP, IOP reduction rate, and adverse drug reactions (ADRs) between the 2 groups.. While the mean IOP reduction rate after 12 months was higher in the TMT group (52.7%) than in the DMT group (50.4%), the difference was not significant (p-value = 0.615). In the TMT group, the rate of proceeding to laser or surgical therapy was 22.2% (DMT group = 37.8%). In the TMT group, the time duration between beginning maximum medical therapy and proceeding to laser or surgical therapy was 10.7 ± 1.3 months (DMT group = 10.3 ± 1.5 months). No serious ADRs were reported in either group. However, the incidence rate of conjunctival hyperemia and dry eye was significantly lower in the DMT group than in the TMT group.. DMT is safe and effective for lowering IOP in POAG patients. DMT is not inferior to TMT in POAG patients.

Topics: Aged; Antihypertensive Agents; Brimonidine Tartrate; Carbonic Anhydrase Inhibitors; Dose-Response Relationship, Drug; Drug Combinations; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmic Solutions; Prostaglandins F; Retrospective Studies; Sulfonamides; Thiazines; Time Factors; Timolol; Treatment Outcome

To determine whether the consumption of topical glaucoma medication is influenced by the type of eye drop dispenser.. Retrospective cohort study.. We examined 366 patients with open-angle glaucoma or ocular hypertension who were bilaterally treated with 0.0015% tafluprost or 2% dorzolamide/0.5% timolol fixed combination (DTFC). The patients were grouped by the type of dispenser and content of eye drops used: (1) tafluprost in bottles (T-Bottle group); (2) tafluprost in unit-dose pipettes (T-Unit group); (3) DTFC in bottles (C-Bottle group); and (4) DTFC in unit-dose pipettes (C-Unit group). We evaluated the medication possession ratio (MPR) among groups, and factors associated with over-consumption (MPR > 1.2) or under-consumption (MPR < 0.8) in multinomial logistic regression.. The mean MPR was 1.49 (range, 0.69-2.91) in the T-Bottle group, 0.91 (range, 0.32-1.27) in the T-Unit group, 1.25 (range, 0.51-2.60) in the C-Bottle group, and 0.96 (range, 0.36-1.60) in the C-Unit group. The Bottle groups demonstrated higher mean values and wider ranges of MPR compared to the Unit groups. The MPR interval at which the largest number of patients were found was 1.0-1.4 in the Bottle groups and 0.8-1.2 in the Unit groups. Bottle-type dispenser (odds ratio [OR] 64.02), tafluprost medication (OR 2.84), and older age (OR 1.03) were associated with over-consumption, whereas no factor was correlated with under-consumption.. The type of eye drop dispenser affects the consumption of glaucoma medication. Physicians should consider the type of eye drop dispenser when assessing glaucoma medication adherence.

Topics: Administration, Ophthalmic; Aged; Antihypertensive Agents; Drug Combinations; Drug Packaging; Drug Utilization; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F; Retrospective Studies; Sulfonamides; Thiophenes; Timolol

Glaucoma treatment has often been associated with adverse side-effects from preservatives that are included in the used eye drops.. To evaluate changes in the ocular surface and the presence of prostaglandin-induced corneal disorders after being switched from latanoprost 0.005% to low preservative tafluprost 0.0015% ophthalmic solution.. Single centre, prospective study.. Patients with primary open-angle glaucoma or ocular hypertension that had received treatment with once daily latanoprost 0.005% ophthalmic solution for control of intraocular pressure (IOP) for 3 months, with a score of above 1 on the National Eye Institute (NEI) ocular surface staining scale.. Following the ≥3 month latanoprost treatment period, patients were switched to once daily low preservative tafluprost 0.0015% ophthalmic solution. Patients were followed for a minimum of 3 months.. Ocular surface changes were assessed by fluorescein staining score (NEI scale). Additional evaluations included tear break-up time, hyperaemia score, subjective symptoms, changes in intraocular pressure and presence of adverse reactions.. Out of 59 patients enrolled, 51 were included in the final analysis. Fluorescein staining scores at baseline, prior to treatment switch, were 6.9 ± 3.1 and 3.3 ± 2.7 at the end of the study period (change in scores was -3.6 ± 2.2 [P < 0.001]). At last follow-up, significant improvements were observed in tear break-up time, hyperaemia score and subjective symptoms (all P < 0.05).. The clinical signs of ocular surface disease and subjective symptoms of dry eyes improved following the switch to low preservative tafluprost and demonstrated comparable IOP lowering effectiveness.

Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Benzalkonium Compounds; Cornea; Corneal Diseases; Drug Substitution; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Off-Label Use; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Treatment Outcome; Young Adult

The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance.. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected.. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years.. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with minimum safety concerns in the actual clinical practice. The observed treatment persistence suggests that tafluprost can be used long term owing to its benefit-risk profile.. Santen Pharmaceutical Co., Ltd., Osaka, Japan.

Topics: Aged; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Japan; Kaplan-Meier Estimate; Low Tension Glaucoma; Male; Middle Aged; Ocular Hypertension; Product Surveillance, Postmarketing; Prospective Studies; Prostaglandins F; Prostaglandins, Synthetic; Risk Assessment; Tonometry, Ocular

Although ocular circulation at the retina and optic disc is known to be associated with the pathology of glaucoma, direct measurement of blood flow velocity has been difficult to obtain. This prospective observational study enrolled 11 consecutive patients with treatment-naïve primary open-angle glaucoma (POAG) and 11 healthy subjects, and the effects of topical tafluprost treatment on ocular circulation were examined at baseline and at 1, 4, and 12 weeks after initiating treatment with topical tafluprost on POAG patients using multiple modalities, which include adaptive optics scanning laser ophthalmoscopy (AOSLO). Baseline mean intraocular pressure (IOP) was significantly higher and mean parafoveal blood flow velocity (pBFV) was significantly lower in POAG eyes than in healthy eyes. Mean IOP was significantly decreased (1 week, -19.1%; 4 weeks, -17.7%; and 12 weeks, -23.5%; all P < 0.001) and mean pBFV was significantly increased from the baseline at all follow-up periods after initiating treatment (1 week, 14.9%, P = 0.007; 4 weeks, 21.3%, P < 0.001; and 12 weeks, 14.3%, P = 0.002). These results reveal that tafluprost may not only lower IOP but may also improve retinal circulation in POAG eyes and AOSLO may be useful to evaluate retinal circulatory change after treatment.

Topics: Administration, Topical; Adult; Blood Flow Velocity; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmoscopy; Prospective Studies; Prostaglandins F; Retinal Vessels; Treatment Outcome

The effects of preservatives of antiglaucoma medications on corneal surface and tear function have been widely shown in literature; it's not the same as regards the active compounds themselves. The purpose of our study was to compare Ocular Surface Disease (OSD) signs and symptoms of Tafluprost 0.0015% versus preservative free (PF) Timolol 0.1% eyedrops in ocular hypertensive (OH) and in primary open-angle glaucoma (POAG) patients.. A cross-sectional study included patients in monotherapy for at least 36 months with Tafluprost 0.0015% (27) or PF Timolol 0.1% (24) and 20 healthy age and sex-matched volunteers. All subjects underwent clinical tests (Schirmer I and break-up time), in vivo confocal microscopy (IVCM) and were surveyed using Ocular Surface Disease Index (OSDI) and Glaucoma Symptoms Scale (GSS) questionnaires. The groups were compared with ANOVA, Kruskal-Wallis test, t-test, Mann-Whitney test and Bonferroni's adjustment of p-values.. No significant differences were found in questionnaires scores, clinical tests, IVCM variables between therapy groups. Tafluprost 0.0015% group showed significantly higher OSDI score, basal epithelial cells density, stromal reflectivity, sub-basal nerves tortuosity (p = 0.0000, 0.037, 0.006, 0.0000) and less GSS score, number of sub-basal nerves (p = 0.0000, 0.037) than controls but similar clinical tests results (p > 0.05). PF Timolol group had significantly higher OSDI score, basal epithelial cells density, stromal reflectivity and sub-basal nerve tortuosity (p = 0.000, 0.014, 0.008, 0.002), less GSS score, BUT and number of sub-basal nerves (p = 0.0000, 0.026, 0.003) than controls.. Compared to PF Timolol 0.1%, Tafluprost 0.0015% showed similar safety with regards to tear function and corneal status and a similar tolerability profile. Both therapy groups show some alterations in corneal microstructure but no side effects on tear function except for an increased tear instability in PF Timolol 0.1% group. Ophtalmologists should be aware that even PF formulations may lead to a mild ocular surface impairment.

Topics: Aged; Antihypertensive Agents; Cross-Sectional Studies; Dose-Response Relationship, Drug; Drug Tolerance; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Microscopy, Confocal; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins F; Tears; Time Factors; Timolol; Tonometry, Ocular; Treatment Outcome

To evaluate the effect of preservative-free (PF) tafluprost on diurnal variation of intraocular pressure (IOP) and ocular perfusion pressure (OPP), measured by use of home IOP and blood-pressure (BP) monitoring devices, for primary open angle glaucoma (POAG) patients.. Twenty-two eyes from 22 patients with POAG were studied. Initially, IOP was measured at the hospital by Goldmann applanation tonometry (GAT) and Icare-ONE rebound tonometry. Each patient was then instructed how to use the Icare-ONE and BP home monitoring devices. IOP and BP were measured at home by the patients, every 4 h, before and 2 weeks after once daily treatment with PF tafluprost (0.0015%) ophthalmic solution.. Intraclass correlations between different IOP measurements were greater than 0.8. PF tafluprost reduced mean diurnal IOP significantly for patients with POAG, from 15.7 ± 1.2 mmHg at baseline to 12.5 ± 0.6 mmHg 2 weeks after treatment (p < 0.001). It increased mean diurnal OPP from 48.5 ± 7.3 mmHg at baseline to 51.3 ± 7.0 mmHg post-treatment (p < 0.017).. Icare-ONE enables glaucoma patients to measure their own diurnal IOP fluctuations. Patient-measured Icare-ONE IOP readings showed that PF tafluprost effectively reduced diurnal IOP in eyes with POAG.

Topics: Adult; Aged; Antihypertensive Agents; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Circadian Rhythm; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmic Solutions; Ophthalmodynamometry; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F; Tonometry, Ocular; Young Adult

To compare the ocular pulse amplitude (OPA) lowering effects of preservative-free tafluprost and dorzolamide-timolol fixed combination (DTFC) using dynamic contour tonometry.. In total, 66 eyes of 66 patients with normal tension glaucoma (NTG) (n = 34) or primary open angle glaucoma (POAG) (n = 32) were included. Patients were divided into two groups: the preservative-free tafluprost-treated group (n = 33) and the preservative-free DTFC-treated group (n = 33). Intraocular pressure (IOP) was measured using Goldmann applanation tonometry (GAT). OPA was measured using dynamic contour tonometry; corrected OPA (cOPA) was calculated at baseline and at 1 week and 1, 3, and 6 months after treatment.. After 6 months of treatment, tafluprost significantly reduced IOP (P < 0.001). The OPA lowering effects differed significantly between the two treatment groups (P = 0.003). The cOPA-lowering effect of tafluprost (1.09 mmHg) was significantly greater than that of DTFC (0.36 mmHg) after 6 months of treatment (P = 0.01).. Tafluprost and DTFC glaucoma treatments provided marked OPA and IOP lowering effects. Tafluprost had a greater effect than DTFC; thus, this drug is recommended for patients at risk of glaucoma progression, due to the high OPA caused by large fluctuations in IOP.

Topics: Drug Combinations; Eye; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Low Tension Glaucoma; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins F; Retrospective Studies; Sulfonamides; Thiophenes; Timolol; Tonometry, Ocular

Primary (or chronic) open-angle glaucoma (POAG or COAG) may be asymptomatic but causes progressive optic nerve damage with significant loss of visual field. Treatments aim to lower intraocular pressure (IOP) by reducing the production of aqueous humour and/or increasing its drainage. Here we update our previous articles to reflect new drugs, preservative-free preparations and fixed-dose drug combinations for POAG.

Topics: Adrenergic beta-Antagonists; Adult; Bimatoprost; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Prostaglandins F; Prostaglandins F, Synthetic

Deepening of the upper eyelid sulcus (DUES), one symptom of prostaglandin-associated periorbitopathy, was recently found to be an additional side effect of prostaglandin-related ophthalmic solutions. Here, we prospectively investigated the incidence and factors associated with DUES in Japanese open-angle glaucoma patients initially treated with benzalkonium chloride (BAK)-preserved tafluprost (TAF).. In this open-label prospective study instilling TAF in one eye, mean deviation (MD) and intraocular pressure (IOP) were measured, and facial photographs and subjective reports of DUES were obtained at intervals over 6 months. Three ophthalmologists independently assessed the photographs of DUES and reached consensus. Relationships between demographic and ocular/systemic factors (age, sex, MD, refraction and IOP reduction) and DUES occurrence were evaluated.. Forty-three eyes of 43 glaucoma patients (24 men and 19 women) were evaluated. Mean IOP before treatment was 16.6 ± 2.7 and after treatment, 14.1 ± 2.3 mmHg (P < 0.001). The objective rate of DUES was 9 % (4/43) at 2 months, 14 % (6/43) at 4 months and 14 % (6/43) at 6 months. During this period, only one patient self-reported an occurrence of DUES. No significant association was found between DUES occurrence and any of the demographic, ocular, or systemic factors.. Physicians should inform patients about DUES as a minor side effect when prescribing TAF for IOP control.

Topics: Antihypertensive Agents; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Incidence; Intraocular Pressure; Low Tension Glaucoma; Male; Middle Aged; Ophthalmic Solutions; Orbital Diseases; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F

To assess the effects on dry eye symptoms and tear dynamics of switching from a prostaglandin with a preservative to a preservative-free prostaglandin.. Fourteen patients (N=28 eyes) with open-angle glaucoma and dry eye symptons, treated with preserved latanoprost, travoprost or bimatoprost were included in this uncontrolled prospective study. Ocular symptoms were analysed using a validated ocular surface disease questionnaire and ocular signs were assessed with tear clearance, Schirmer and tear function index test (TFI=Schirmer/clearance). Patients were assigned to preservative-free tafluprost treatment, and measurements were repeated 4 weeks after change of medication. Wilcoxon test and Spearman correlation coefficient were used in the statistical analysis.. No statistically significant difference in intraocular pressure (IOP) was observed after switching to tafluprost. Mean IOP at baseline was 20.4 mmHg (SD2.2) and after 4 weeks 19.9 mmHg (SD2.6), (P>.05). The mean questionnaire score significantly decreased from 9.7 (SD3.7) at baseline to 5.4 (SD2.7) after one month (P<.001). No significant differences in tear clearance, Schirmer or TFI were found (P>.05). At baseline, tear clearance=0.13 (SD0.07), Schirmer=10.7 mm (SD6) and TFI=80 (48-156). After 4 weeks, tear clearance=0.1(SD0.07), Schirmer=9.5 mm (3.9) and TFI=104 (48-216). A significant association between questionnaire score and tear clearance after 4 weeks was observed (Spearman coefficient=0.62; P=.014).. Switching from preservative prostaglandin with a preservative to preservative-free tafluprost treatment improves dry eye symptoms and suggests an improvement in TFI.

Topics: Aged; Dry Eye Syndromes; Female; Glaucoma, Open-Angle; Humans; Male; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins; Prostaglandins F; Tears

To record the impact of preservative-free Tafluprost on corneal status examined by in vivo confocal microscopy.. A prospective cohort study on consecutive naïve or previously treated patients with a new prescription of preservative-free Tafluprost. All subjects underwent a complete ophthalmic examination [comprehensive of intraocular pressure (IOP) and central corneal thickness (CCT) measurements], and an in vivo corneal confocal microscopy evaluation, at baseline and 12 months later. A healthy control group was selected and examined at the same time.. Seventy-five subjects (16 controls, 20 naïve, and 39 treated) were enrolled. At baseline, IOP was 16 (13.8-18.6), 21.5 (18-23.7), and 18 (16-22) mmHg, (P=0.01); and CCT did not differ among the groups (P=0.25). Epithelial cells, keratocyte activation, a number of sub-basal nerves, and the grade of nerve tortuosity were similar (P=0.233, 0.11, 0.417, and 0.05, respectively), in naïve and controls, while previously treated patients had significantly less epithelial cells and sub-basal corneal nerves (P<0.0001), keratocyte activation, increased number of bead-like formations, and nerve tortuosity (P<0.0001). At month 12, IOP decreased in both patient groups (P<0.001); CCT did not change. Previously treated patients showed an improvement in confocal parameters: increased epithelial cells (P=0.0006), reduced keratocyte activation (P=0.003), increased number of corneal nerves (P=0.0004), decreased number of bead-like formations (P=0.0013), and nerve tortuosity (P=0.0008). Naïve patients did not show significant changes.. The study confirmed the efficacy of preservative-free Tafluprost in reducing IOP, and underlined the drug's safety in naïve glaucoma patients with regard to corneal status. In the balance between efficacy and tolerability, formulations with low cytotoxicity may ensure fewer side effects, with higher tolerability and better compliance.

Topics: Administration, Ophthalmic; Aged; Antihypertensive Agents; Case-Control Studies; Cohort Studies; Cornea; Corneal Keratocytes; Endothelium, Corneal; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Microscopy, Confocal; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F; Single-Blind Method

We report a case of Urrets-Zavalia Syndrome after a glaucoma filtration device (g.f.d.) implantation. A 74-year-old woman with bilateral advanced glaucoma has been planned for surgery. The patient underwent to g.f.d. implantation in the right eye. On postoperative day 1, the patient had an edematous cornea with a dilated and non reactive pupil. In this article we describe the clinical history of this patient. To our knowledge, this is the first case of Urrets-Zavalia Syndrome after a g.f.d. implantation.

Topics: Acetazolamide; Aged; Brimonidine Tartrate; Cataract Extraction; Combined Modality Therapy; Drug Resistance; Drug Therapy, Combination; Female; Glaucoma Drainage Implants; Glaucoma, Open-Angle; Humans; Hypertension; Miotics; Mydriasis; Ocular Hypertension; Pilocarpine; Prostaglandins F; Quinoxalines; Sulfonamides; Syndrome; Thiophenes; Timolol

Topics: Administration, Ophthalmic; Drug Approval; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Ophthalmic Solutions; Prostaglandins F; United States; United States Food and Drug Administration

We investigated the appearance frequency of eyelid pigmentation and eyelash bristles after the use of five types of prostaglandin (PG) analogs.. This study included 250 eyes from 250 patients diagnosed with primary open-angle glaucoma or ocular hypertension who were treated with either latanoprost, travoprost, tafluprost, bimatoprost, or isopropyl unoprostone for >3 months in only one eye. Photographs of both eyes were obtained, and the images were assessed by three ophthalmologists who were masked to treatment type. The existence of eyelid pigmentation and eyelash bristles was judged, and images of the left and right eyes were compared. Subjective symptoms regarding the existence of eyelid pigmentation and eyelash bristles were investigated through a questionnaire.. There was no significant difference between the five types of medications with regard to eyelid pigmentation (P=0.537). Use of isopropyl unoprostone resulted in a significantly lower incidence of eyelash bristles (P<0.0001). The questionnaire investigation showed that eyelid pigmentation and eyelash bristles were significantly more frequent with travoprost (42.0% and 42.0%, respectively) and bimatoprost (58.0% and 60.0%, respectively) than with other three medications (P<0.0001).. The appearance frequency of eyelid pigmentation was similar among the five types of PG analogs studied, and eyelash bristles appeared less frequently with isopropyl unoprostone use. Patients are conscious of eyelash bristles; therefore, these adverse effects should be sufficiently explained to patients before PG administration.

Topics: Adult; Aged; Aged, 80 and over; Amides; Antihypertensive Agents; Bimatoprost; Cloprostenol; Dinoprost; Eyelashes; Eyelid Diseases; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Male; Middle Aged; Ocular Hypertension; Prospective Studies; Prostaglandins F; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Skin Pigmentation; Surveys and Questionnaires; Travoprost

The purpose of this study was to investigate the tolerability and intraocular pressure (IOP) reducing effect of the first preservative-free prostaglandin tafluprost (Taflotan) in patients exhibiting ocular surface side-effects during latanoprost (Xalatan) treatment.. A total of 158 patients were enrolled in this open-label multicentre study. Eligible patients had to have at least two ocular symptoms, or one sign and one symptom, during treatment with latanoprost. At baseline, the patients were directly switched from latanoprost to preservative-free tafluprost for 12 weeks. The patients were queried for ocular symptoms, and ocular signs were assessed by using tear break-up time, Schirmer's test, fluorescein staining and evaluation of conjunctival hyperaemia and blepharitis. In addition, HLA-DR and MUC5AC in conjunctival impression cytology specimens were analyzed, and a drop discomfort/quality of life (QoL) questionnaire was employed. IOP was measured at all visits.. Preservative-free tafluprost maintained IOP at the same level after 12- weeks treatment (16.4 +/- 2.7 mmHg) as latanoprost at baseline (16.8 +/- 2.5 mmHg). During treatment with preservative-free tafluprost, the number of patients having irritation/burning/stinging (56.3%), itching (46.8%), foreign body sensation (49.4%), tearing (55.1%) and dry eye sensation (64.6%) decreased to 28.4%, 26.5%, 27.1%, 27.1% and 39.4% correspondingly. The number of the patients with abnormal fluorescein staining of cornea (81.6%) and conjunctiva (84.2%), blepharitis (60.1%), conjunctival hyperaemia (84.2%) and abnormal Schirmer's test (71.5%) was also reduced significantly to 40.6%, 43.2%, 40.6%, 60.0% and 59.4% correspondingly. The tear break-up time improved significantly from 4.5 +/- 2.5 seconds to 7.8 +/- 4.9 seconds. A reduction in the number of patients with abnormal conjunctival cells based on HLA-DR and MUC5AC was also detected.. Preservative-free tafluprost maintained IOP at the same level as latanoprost, but was better tolerated in patients having signs or symptoms while on preserved latanoprost. Preservative-free tafluprost treatment resulted in improved QoL, increased patient satisfaction and drop comfort.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Benzalkonium Compounds; Blepharitis; Conjunctival Diseases; Exfoliation Syndrome; Female; Glaucoma, Open-Angle; Gonioscopy; HLA-DR Antigens; Humans; Hyperemia; Intraocular Pressure; Latanoprost; Male; Middle Aged; Mucin 5AC; Ocular Hypertension; Ophthalmoscopy; Patient Satisfaction; Preservatives, Pharmaceutical; Prostaglandins F; Prostaglandins F, Synthetic; Quality of Life; Surveys and Questionnaires; Tonometry, Ocular