Preservative-free Tafluprost Research Articles

Comparing the tolerability of preservative-free tafluprost versus preserved latanoprost in the management of glaucoma and ocular hypertension - an observer blinded active-control trial.

Dry eye is a condition related to long-term topical eye therapy. We wish to evaluate the effectiveness and tolerability of preservative free prostaglandin drops versus benzalkonium chloride containing prostaglandin drops in the treatment of glaucoma. Patients undergoing prostaglandin monotherapy underwent a washout period of at least 1 month after which baseline measurements of dry eye severity were taken. Patients were randomised to receive either 0.0015% tafluprost drops or 0.005% latanoprost preserved with 0.02% benzalkonium chloride. Repeat measurements were taken after a 2-month interval. Thirty-five patients completed randomised treatment. No significant difference between groups was found in objective and subjective measurements of dry eye severity. No significant difference was found in measurement of treatment effectiveness. Preservative-free and benzalkonium chloride-containing drops were found to be equally effective in lowering IOP with no significant difference in either subjective or objective measurements of dry eye severity.

Comparing the effect of benzalkonium chloride‐preserved, polyquad‐preserved, and preservative‐free prostaglandin analogue eye drops on cultured human conjunctival goblet cells

Aims/Purpose: To investigate the effect of benzalkonium chloride (BAK)‐preserved latanoprost and bimatoprost, polyquad (PQ)‐preserved travoprost, and preservative‐free (PF) latanoprost and tafluprost, all prostaglandin analogues (PGAs), on human conjunctival goblet cell (GC) survival. Furthermore, to investigate the effect of BAK‐preserved and PF latanoprost on the cytokine secretion from GC.Methods: Primary human conjunctival GCs were cultivated from donor tissue. Lactate dehydrogenase (LDH) and tetrazolium dye colorimetric (MTT) assays were used for the assessment of GC survival. A cytometric bead array was employed for measuring secretion of interleukin (IL)‐6 and IL‐8 from GC.Results: BAK‐preserved latanoprost and bimatoprost reduced cell survival by 28% (p = 0.0133) and 20% (p = 0.0208), respectively, in the LDH assay compared to a negative control. BAK‐preserved latanoprost reduced cell proliferation by 54% (p = 0.003), BAK‐preserved bimatoprost by 45% (p = 0.006), PQ‐preserved travoprost by 16% (p = 0.0041), and PF latanoprost by 19% (p = 0.0001), in the MTT assay compared to a negative control. Only PF tafluprost did not affect the GCs in either assay. BAK‐preserved latanoprost caused an increase in the secretion of pro‐inflammatory IL‐6 and IL‐8 (p = 0.0001 and p = 0.0019, respectively) compared to a negative control, which PF latanoprost did not.Conclusions: BAK‐preserved PGA eye drops were more cytotoxic to GCs than PQ‐preserved and PF PGA eye drops. BAK‐preserved latanoprost induced an inflammatory response in GC. Treatment with PF and PQ‐preserved PGA eye drops could mean better tolerability and adherence in glaucoma patients compared to treatment with BAK‐preserved PGA eye drops.

Comparing the effect of benzalkonium chloride-preserved, polyquad-preserved, and preservative-free prostaglandin analogue eye drops on cultured human conjunctival goblet cells

PurposeTo investigate the effect of benzalkonium chloride (BAK)-preserved latanoprost and bimatoprost, polyquad (PQ)-preserved travoprost, and preservative-free (PF) latanoprost and tafluprost, all prostaglandin analogues (PGAs), on human conjunctival goblet cell (GC) survival. Furthermore, to investigate the effect of BAK-preserved and PF latanoprost on the cytokine secretion from GC. MethodsPrimary human conjunctival GCs were cultivated from donor tissue. Lactate dehydrogenase (LDH) and tetrazolium dye colorimetric (MTT) assays were used for the assessment of GC survival. A cytometric bead array was employed for measuring secretion of interleukin (IL)-6 and IL-8 from GC. ResultsBAK-preserved latanoprost and bimatoprost reduced cell survival by 28% (p = 0.0133) and 20% (p = 0.0208), respectively, in the LDH assay compared to a negative control. BAK-preserved latanoprost reduced cell proliferation by 54% (p = 0.003), BAK-preserved bimatoprost by 45% (p = 0.006), PQ-preserved travoprost by 16% (p = 0.0041), and PF latanoprost by 19% (p = 0.0001), in the MTT assay compared to a negative control. Only PF tafluprost did not affect the GCs in either assay. BAK-preserved latanoprost caused an increase in the secretion of pro-inflammatory IL-6 and IL-8 (p = 0.0001 and p = 0.0019, respectively) compared to a negative control, which PF latanoprost did not. ConclusionBAK-preserved PGA eye drops were more cytotoxic to GCs than PQ-preserved and PF PGA eye drops. BAK-preserved latanoprost induced an inflammatory response in GC. Treatment with PF and PQ-preserved PGA eye drops could mean better tolerability and adherence in glaucoma patients compared to treatment with BAK-preserved PGA eye drops.

The evaluation of the effect of tafluprost on the intraocular pressure of healthy male guinea pigs under different light-and-darkness regimes.

Ocular hypertension is one of the most underdiagnosed ocular abnormalities among guinea pigs around the world. The current study investigates the effect of 0.0015% preservative-free tafluprost ophthalmic solution (Zioptan) on the intraocular pressure of 16 healthy male guinea pigs (Cavia porcellus) under different light/darkness regimes. All guinea pigs received a single drop of tafluprost at 5:30 in the right eye, whereas the contralateral eyes served as control to receive a placebo. Then, the animals were randomly divided into two groups; group A was exposed to light, whereas group B was placed in darkness from 5:30 to 18:00. Rebound tonometry (TonoVet) was instrumented to measure IOP values at 5:30 (baseline), 6:00, 7:00, 8:00, 9:00 and then every 3h until 18:00. The maximum IOP reduction associated with tafluprost was observed at 6:00 by -1.4±1.1mmHg (p-value=0.026) and -2.5±1.2mmHg (p-value=0.011) in group A and B, respectively (repeated measure ANOVA test). There was a significant difference between the mean right and left eye IOP values in both groups at 5:30, 6:00, 7:00 and 8:00 (p-value <0.05), which was greater in amount in group B compared to group A due to the effect of darkness on IOP reduction. It is suggested that the variations of IOP in different light/dark conditions be taken into consideration when applying ocular hypotensive agents on guinea pigs' eyes.

Reviewing the evidence surrounding preservative-free tafluprost/timolol fixed-dose combination therapy in open-angle glaucoma and ocular hypertension management: a focus on efficacy, safety, and tolerability

ABSTRACT Introduction 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). Areas covered 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. Expert opinion 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).

A comparison of country-level data from the VISIONARY study examining treatment outcomes with preservative-free tafluprost/timolol fixed-dose combination therapy

Objective 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. Methods 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 t-test was used to assess significance regarding mean IOP reduction from baseline and a compound symmetry covariance model was used in cross-country comparisons regarding variation in IOP change from baseline. Treatment-related adverse events (AEs) were evaluated. Results Mean (SD) age among patients recruited to the VISIONARY study ranged between 63.9 (11.8) and 72.4 (10.6) years across all countries. The majority of participants (>50%) were female in each country. The Country-level Subanalysis Population included 551 eyes. Mean (SD) IOP was significantly reduced from baseline in each country at Week 4, Week 12 and Month 6 (p < .0001). Mean IOP reduction at Month 6 ranged from 5.0 mmHg (22.6%, Hungary) to 7.8 mmHg (31.8%, Latvia) and varied significantly between countries (p < .001). The greatest reductions were in Latvia and Russia, where baseline IOP was highest. Country-level IOP reductions were significant irrespective of prior monotherapy, diagnosis or dosing time (p < .0001). Most treatment-related AEs occurred in the UK (26 events, 73% mild). One serious AE was reported (Russia, status asthmaticus). Tolerability with PF tafluprost/timolol FC therapy was rated as good/very good by most patients (85.7–100%) in all countries. Conclusion 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.

Is it time for a moratorium on the use of benzalkonium chloride in eyedrops?

Is it time for a moratorium on the use of benzalkonium chloride in eyedrops?

Treatment of open-angle glaucoma and ocular hypertension with preservative-free tafluprost/timolol fixed-dose combination therapy: 6 case reports and clinical outcomes

BackgroundTreatment 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).Case presentationSix 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).ConclusionsIn 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.

Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: Results from the VISIONARY Study Population in Spain.

Purpose:Data are presented from ophthalmology clinics in Spain participating in the VISIONARY study, examining the effectiveness, tolerability, and safety of the preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in the treatment of OAG and OHT.Methods:An observational, multicenter prospective study examined treatment outcomes following a switch to PF tafluprost/timolol FC in adult OAG/OHT patients demonstrating insufficient response to beta-blocker or prostaglandin analog (PGA) monotherapy. Primary end point was mean change in intraocular pressure (IOP) from baseline at month 6. Changes in the severity of ocular signs and symptoms were also assessed.Results:Overall, 92 patients (51.1% female) were included. Mean (standard deviation) age was 68.3 (12.1) years. Mean IOP was reduced from 21.9 mmHg at baseline to 16.7 mmHg at month 6 (22.3% decrease; P < 0.0001). Significant IOP reductions were observed at weeks 4 and 12 (P < 0.0001). Baseline PGA and beta-blocker users demonstrated mean month 6 IOP reductions of 5.5 mmHg (23.5%; P < 0.001) and 3.5 mmHg (14.6%; P = 0.029), respectively. Severity of conjunctival hyperemia, dry eye, irritation, itching, foreign body sensation, and eye pain was significantly reduced. Three treatment-related adverse events were reported, all were nonserious and mild/moderate in severity.Conclusion:In real-world clinical practice, PF tafluprost/timolol FC treatment provided significant IOP reductions over 6 months and was well tolerated among OAG/OHT patients showing poor response to PGA or beta-blocker monotherapy. IOP-lowering efficacy and improvements in ocular signs and symptoms were evident from week 4 and maintained over the 6-month study period. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number EUPAS22204.

Efficacy, Safety and Patient-Reported Outcomes with Preservative-Free (PF) Tafluprost or PF-Dorzolamide/Timolol Compared with Preserved Latanoprost: A Prospective Multicenter Study in Korean Glaucoma Patients with Ocular Surface Disease.

To compare the efficacy, patient-reported satisfaction, and safety of preservative-free (PF)-tafluprost, PF-dorzolamide/timolol and preservative-containing (P)-latanoprost in Korean glaucoma patients with ocular surface disease (OSD). In a multicenter, prospective, interventional, non-randomized, controlled 12-week trial, 107 eligible patients received PF-tafluprost (n = 37), PF-dorzolamide/timolol (n = 34), or P-latanoprost eye drops (n = 36). Outcomes included changes from baseline in OSD Index (OSDI) scores (primary endpoint), intraocular pressure (IOP), and patient-reported treatment satisfaction, and safety at 12 weeks. At 12 weeks, the mean total OSDI and subdomain (dry eye symptoms, visual-related function, environmental triggers) scores significantly improved from baseline with PF-tafluprost and PF-dorzolamide/timolol, but not with P-latanoprost. Significantly more PF-tafluprost than P-latanoprost recipients reported ‘highly improved/improved’ satisfaction (no significant difference between PF-dorzolamide/timolol and P-latanoprost). IOP changes were comparable among all three treatment groups. No new safety concerns were observed. PF-tafluprost and PF-dorzolamide/timolol showed statistically and clinically significant reductions in OSDI compared with P-latanoprost in Korean glaucoma patients with OSD.

Effects of 0.0015% preservative-free tafluprost on the equine eye.

The purpose of this study was to determine the effects and potential side effects of topical preservative-free (PF) tafluprost 0.0015% in ophthalmologically normal horses. Five adult grade horses. One of the eyes of each horse was randomly chosen as the "treatment" eye, and consequently, the contralateral eye served as the "control." A single dose of PF tafluprost 0.0015% (0.2mL) was instilled in the treated eye of each horse. Intraocular pressure (IOP), Schirmer's tear test (STT) levels of each eye, and an ophthalmic examination were performed at T0 (baseline), T30, T120, T24h, and T48h. The mean IOP values of the treated eyes at baseline (T0), T30, T120, T24h, and T48h were 25.4±4.8mmHg, 21.2±1.92mmHg, 15.20±2.48mmHg, 18.40±1.51mmHg, and 24.60±1.94mmHg, respectively. Significant differences were observed between the mean baseline IOP level and the T120 and T24h time points (p=.001 and p=.009). The mean STT levels at each time point showed insignificant fluctuations during the study (p=.140). Adverse effects such as chemosis and episcleral injection were observed 30min after the instillation of tafluprost 0.0015% (T30). Blepharospasm and conjunctival hyperemia were observed 120min (T120) after the administration of the medication. Tafluprost 0.0015% showed potential in reducing IOP, but due to its local side effects, it is not a good candidate for management of glaucoma in horses. Tafluprost did not notably affect STT.

Ocular surface conditions in Asian glaucoma patients with existing corneal disorders switching from preserved prostaglandin analogue monotherapy to preservative-free tafluprost

Introduction: Glaucoma medications are often preserved with agents such as benzalkonium chloride, which commonly lead to ocular surface diseases.Purpose: To investigate the effect of switching to a preservative-free prostaglandin analogue, tafluprost 0.0015% on treatment tolerability and ocular surface diseases.Study design: This was a prospective, open-label, non-randomised, observational study performed in a single hospital.Materials and methods: This study involved patients of Asian descent diagnosed with primary open-angle glaucoma and ocular hypertension (n = 28), who received preserved prostaglandin monotherapy for longer than 3 months and had a National Eye Institute ocular surface staining scale score higher than 1. Patients were switched from preserved prostaglandin monotherapy to preservative-free tafluprost 0.0015%. Patients were analysed at baseline (Visit 0), 1 month (Visit 1), and 3 months (Visit 2). The main parameter measured is the change in the fluorescein staining score at Visit 2.Results: There was a significant improvement in the fluorescein staining score, with a mean reduction score of 1.96 (standard deviation, SD = 1.53; p &lt; 0.0001), and significant reductions in conjunctival hyperaemia (bulbar, p &lt; 0.0001; palpebral, p &lt; 0.05) from baseline to Visit 2. The Ocular Surface Disease Index questionnaire also showed a mean reduction of 4.14 from baseline to visit 2 (SD = 8.20; p &lt; 0.05). The intraocular pressure and tear breakup time were maintained from baseline to Visit 2.Conclusion: Switching patients to preservative-free tafluprost 0.0015% showed significant improvements in ocular surface disease with minimal side effects and similar intraocular pressure reduction rates.

A comparison between the effect of topical tafluprost and latanoprost on intraocular pressure in healthy male guinea pigs

This study was aimed to evaluate the effect of 0.0015% preservative-free tafluprost (Zioptan®) and 0.005% preservative containing latanoprost ophthalmic solutions (Lataprost®) on intraocular pressure (IOP) in healthy male guinea pigs (Cavia porcellus). A total of 16 male guinea pigs were randomly assigned to receive one drop of tafluprost or one drop of latanoprost in the right eye. The contralateral eye served as control. IOP was measured using a rebound tonometer at time 0(baseline), after 30 minutes and every 60 minutes for the next three hours and then every three hours for the next 21 hours. Administration of tafluprost and latanoprost was not associated with changes in IOP in the treated eyes. The maximum IOP-lowering effect of the ophthalmic solutions was observed 30 minutes post-instillation in the treated eyes (-1.25 ± 1.50 mmHg, P-value = 0.194 in group A and -1.50 ± 1.29 mmHg, P-value = 0.103 in group B) and returned to normal after 9 and 12 hours in group A and B, respectively. There was no significant difference between the IOP measurements of the right and left eyes in neither groups during the study (repeated measure test and Generalized Linear Mixed Model). The administration of one drop of tafluprost and latanoprost had no significant effect on the IOP of healthy guinea pigs. Further studies are needed in guinea pigs affected by glaucoma to explore the effectiveness of these drugs.

Comparison of the Safety and Efficacy between Preserved and Preservative-Free Latanoprost and Preservative-Free Tafluprost.

In this study, we investigated the effect of preservative-free (PF) 0.0015% tafluprost (TA), to the preservative containing (PC) and the PF 0.005% latanoprost (LA) in Korean subjects. This study was conducted as a multi-center, randomized, investigator-blind, active controlled, parallel-group, clinical trial in adult patients (≥19 years) with open-angle glaucoma (OAG) and ocular hypertension (OHT). After a washout period, patients with an IOP between 15 and 35 mmHg were enrolled and evaluated the efficacy, safety, and compliance at 4, 8 and 12 weeks after the first administration. A total of 137 OAG and OHT patients were randomized. Statistically significant reductions in IOP were observed in all groups. Twelve weeks after each eye drop instillation, the mean IOP reduction was −4.59 ± 2.70 mmHg (−24.57 ± 13.49%) in the PC-LA group, −4.52 ± 2.17 mmHg (−24.41 ± 11.38%) in the PF-LA, and −3.14 ± 2.83 mmHg (−17.22 ± 14.57%) in the PF-TA group. The PF-LA showed significantly better responsiveness than did PF-TA. PF-LA was better tolerated than was PC-LA. There were no adverse events that led to cessation of eye drop use in any of the groups. In conclusion, IOP decreased similarly across the groups. PF-LA may provide a good choice for OAG patients with ocular surface diseases.

Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: UK and Ireland Results from the VISIONARY Study

IntroductionReducing 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.MethodsThis 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.ResultsEighty-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.ConclusionsTreatment 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.Trial registrationEuropean Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01725-7.

Preservative free tafluprost in the medical treatment of POAG in patients with type 2 diabetes mellitus.

Introduction: Long term glaucoma therapy results in the deterioration of the anterior surface of the eye that it usually negatively affects adherence to prescribed therapy and its efficacy. Material and methods: The study included 74patients aged 50-62years with newly diagnosed primary open-angle glaucoma (POAG) on initial stage which were divided into two groups: main (52patients with type 2diabetes mellitus) and control (22patients without diabetes mellitus). In both groups patients obtained one instillation of PF Tafluprost 0.0015%(Taflotan®, Santen, Finland) daily. The term of follow up was 12months.. Results: The results demonstrated that using of PF tafluprost drops has a high percentage of safety as regard possible local side effects, high hypotensive efficacy and adherence. During the entire observation period the state of the anterior surface of eyes almost in all cases was comparable with the initial data and the data of questionnaire. Evaluation of the IOP revealed the sufficient level of IOP reduction by 25-30% in all patients. The SAP data showed a slight decrease of MD index at the level of 0.36dB, that according to the 5-th edition of «Terminology and Guidelines for glaucoma» corresponds to the positive dynamics of the course of glaucomatous optic neuropathy in main and control groups. Conclusions: Long-term use of preservative-free eye drops 0.0015%tafluprost (Taflotan®, Santen, Finland) provided a high hypotensive effect with stable functional state of the optic nerve and safety of the anterior eye surface without the appearance of clinical signs of DED in glaucoma patients with and without 2 type DM.

Crossover randomized study comparing the efficacy and tolerability of preservative-free Tafluprost 0.0015% to Latanoprost 0.005% in patients with primary open-angle glaucoma.

Purpose: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).Methods: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.Results: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 2nd and 5th month (P < 0.001and P = 0.026 respectively) but not after TP treatment (P = 0.719 and P = 0.164). Significant exacerbation in all patients’ symptoms was noticed on switching from TP to LP.Conclusion: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.

Ocular Surface Changes After Switching from Other Prostaglandins to Tafluprost and Preservative-Free Tafluprost in Glaucoma Patients.

PurposeTo study ocular surface disease (OSD) changes after switching from preserved prostaglandin analogues monotherapy to preserved tafluprost and preservative-free (PF) tafluprost in primary open-angle glaucoma patients.MethodsGlaucoma patients treated with preserved prostaglandins (except tafluprost) monotherapy for at least 6 months, intraocular pressure (IOP) ≤22 mmHg, and diagnosed of OSD [≥1 criterion; tear break-up time (TBUT) ≤10 seconds, corneal fluorescein staining ≥grade 1] in both eyes were enrolled in a prospective, randomized, single-blinded study. All eligible patients were switched from preserved prostaglandin analogues monotherapy (latanoprost, bimatoprost, travoprost) to preserved tafluprost in one eye (group I) and PF-tafluprost in the other eye (group II) of the same patient by randomization. The symptoms of OSD were evaluated using the visual analogue scale, and lid inflammation, conjunctival hyperemia, TBUT, corneal fluorescein staining, and Schirmer I test were applied to assess the clinical signs. All parameters were evaluated before and then 6, 12, 24 weeks after switching the medications.ResultsThirty patients (80% women; mean age: 61.2 ±11.5 years) were included. Baseline parameters were not different between the treatment groups. After switching therapies, TBUT was significantly increased in both groups (p = 0.002, p = 0.004, respectively); however, group II had better tear quality. Other symptoms and clinical signs of OSD were improved and IOP was controlled in both groups.ConclusionTreatment with PF-tafluprost improves TBUT better than preserved tafluprost, suggesting that PF-tafluprost should be especially beneficial for patients with pre-existing OSD. Less or no preservative anti-glaucoma eye drops can restore and enhance the ocular surface in glaucoma patients.

Effects of topical administration of tafluprost and combination of tafluprost and timolol or tafluprost and betaxolol on Schirmer tear test, intraocular pressure, and pupil size in clinically healthy dogs.

The aim of this study was to evaluate the effects of 0.0015% preservative-free (PF) tafluprost alone and in combination with 0.5% timolol maleate or0.5% betaxolol HCl on Schirmer tear test (STT), intraocular pressure (IOP), and pupil diameter (PD) in clinically normal dogs. Twenty-one healthy adult castrated male cross-bred dogs were used in this study. Dogs were randomly divided into three groups. The first group received one drop of (PF) tafluprost (Taf), in a randomly selected eye. The second group received one drop of (PF) tafluprost plus one drop of timolol maleate (Taf-Tim), and the last group received one drop of (PF) tafluprost plus one drop of betaxolol HCl, (Taf-Bet). In all groups, the fellow eyes were served as control and received one drop of saline as a placebo. IOP, STT, and PD measurements were performed at the baseline and every 30min for the first 2h, every 2 h for the next 10 h, and at 24h and 36h post-instillation (PI). In all groups, significant differences in IOP values were observed between treated and untreated eyes (Taf: p < 0.001, Taf-Tim: p = 0.014, Taf-Bet: p = 0.008). The maximum reduction in mean IOP after unilateral administration of Taf, Taf-Tim, and Taf-Bet was 8.3mmHg, 10.7mmHg, and 13mmHg, respectively. No significant differences in STT values were observed between treated and untreated eyes at any time points. In all groups, significant differences in PD values were observed between treated and untreated eyes in all time points except the baseline and 36h post-drug instillation (p < 0.001). Tafluprost alone or in combination with timolol and betaxolol was able to reduce intraocular pressure. The greatest effect of the drugs occurred 6 and 8h PI. The present study revealed that the combination of tafluprost/betaxolol is more potent in decreasing IOP than tafluprost alone or a combination of tafluprost/timolol in healthy dogs.

Correction to: 24-Hour Efficacy and Ocular Surface Health with Preservative-Free Tafluprost Alone and in Conjunction with Preservative-Free Dorzolamide/Timolol Fixed Combination in Open-Angle Glaucoma Patients Insufficiently Controlled with Preserved Latanoprost Monotherapy.

In the original article, the incorrect Open Access License type has been incuded.