Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients

Konstas, A. G. P.; Katsanos, Andreas; Athanasopoulos, George; Voudouragkaki, Irini C.; Panagiotou, Evangelia S; Pagkalidou, Eirini; Haidich, Anna‐Bettina; Giannoulis, Dimitrios A; Spathi, Eleni; Giannopoulos, Theodoros; Katz, L. Jay

doi:10.1080/14656566.2018.1534958

Cited by 18 publications

(22 citation statements)

References 44 publications

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“…In this real-world study, no washout period between the prior and study medication was used, even when the prior medication was not optimally tolerated and patients with ocular surface abnormalities were included. Thus, in contrast to the randomized clinical trials previously conducted on the PF tafluprost/timolol FC, in which a complete washout period was used and the patients had to be free from ocular surface abnormalities, in the current investigation we mirrored real-life clinical practice, which is particularly important to all ophthalmologists [10,[14][15][16].…”

Section: Discussionmentioning

confidence: 99%

“…Randomized controlled trials demonstrated a low rate of conjunctival hyperemia with PF tafluprost/timolol FC treatment [14,15]. A recent 24-h investigation also showed that PF tafluprost/timolol FC was associated with less frequent and less severe hyperemia compared with the prestudy period on preserved latanoprost treatment [10].…”

Section: Introductionmentioning

confidence: 99%

“…Prostaglandin analogue (PGA) and beta-receptor blocker (typically timolol 0.5%) combination therapies are among the most extensively used medications in glaucoma care [6,8]. Fixed-dose combination (FC) formulations are frequently used in preference to the administration of the corresponding concomitant medications, since they simplify the treatment regimen and reduce the number of daily instillations as well as the total amount of preservatives applied to the eye [1,6,7,[9][10][11].…”

Section: Introductionmentioning

confidence: 99%

“…Preservative-free (PF) topical glaucoma therapy has become increasingly used in the management of glaucoma worldwide [7,[10][11][12][13][14][15][16][17][18]. Preservatives, and in particular benzalkonium chloride (BAK), the most commonly used preservative, have been shown to induce and seriously worsen ocular surface disease (OSD) [7,[19][20][21][22][23][24].…”

Section: Introductionmentioning

confidence: 99%

“…The overall quantity of BAK used throughout a patient's lifetime is also inversely related to filtration surgery success [7,[19][20][21][22][23][24][25][26][27]. The fixed combination of tafluprost 0.0015% and timolol 0.5% was one of the first PF PGA/timolol FCs used for the treatment of OAG and ocular hypertension (OHT) [10,[14][15][16][17][18]. Randomized controlled trials demonstrated a low rate of conjunctival hyperemia with PF tafluprost/timolol FC treatment [14,15].…”

Section: Introductionmentioning

confidence: 99%

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Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study

et al. 2020

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Introduction: 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. Methods: 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.Results: 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 C 20%, C 25%, C 30%, and C 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. Conclusion: 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. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.The members of The VISIONARY Study Group are listed in Acknowledgements. Key Summary PointsWhy carry out this study?Prostaglandin analogue (PGA) and betareceptor blocker combination therapies are among the most extensively used intraocular pressure (IOP)-lowering treatments in glaucoma care. Fixed-dose combinations simplify the treatment regimen and reduce the number of daily instillations, compared with administration of the corresponding concomitant medications, and preservative-free formulations are generally considered to offer improved tolerability.The VISIONARY study aimed to provide real-world data concerning the treatment effectiveness of the preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in people with open-angle glaucoma (OAG) and ocular hypertension (OHT) who demonstrated an insufficient response ...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study

et al. 2020

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Circadian Variation in Efficacy of Medications

Walton

Walker

Bumgarner

et al. 2020

Clin Pharma and Therapeutics

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Although much has been learned about circadian clocks and rhythms over the past few decades, translation of this foundational science underlying the temporal regulation of physiology and behavior to clinical applications has been slow. Indeed, acceptance of the modern study of circadian rhythms has been blunted because the phenomenology of cyclic changes had to counteract the 20th century dogma of homeostasis in the biological sciences and medicine. We are providing this review of clinical data to highlight the emerging awareness of circadian variation in efficacy of medications for physicians, clinicians, and pharmacists. We are suggesting that gold‐standard double‐blind clinical studies should be conducted to determine the best time of day for optimal effectiveness of medications; also, we suggest that time of day should be tracked and reported as an important biological variable in ongoing clinical studies hereafter. Furthermore, we emphasize that time of day is, and should be considered, a key biological variable in research design similar to sex. In common with biomedical research data that have been historically strongly skewed toward the male sex, most pharmaceutical data have been skewed toward morning dosing without strong evidence that this is the optimal time of efficacy.

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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

et al. 2021

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Introduction 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. Methods 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. Results 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. Conclusions 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. Trial registration European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01725-7.

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Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients

Cited by 18 publications

References 44 publications

Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study

Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study

Circadian Variation in Efficacy of Medications

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

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