scholarly journals Effects of preservative-free tafluprost on tear film osmolarity, tolerability, and intraocular pressure in previously treated patients with open-angle glaucoma

2012 ◽  
pp. 103 ◽  
Author(s):  
Ingrida Januleviciene
Keyword(s):  
Intraocular Pressure ◽  
Open Angle Glaucoma ◽  
Tear Film ◽  
Open Angle ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Preservative Free

scholarly journals Preservative-free versus preserved latanoprost eye drops for reducing intraocular pressure: a non-inferiority phase III randomized, multi-center, single-blind, parallel-group controlled trial

2021 ◽  
Vol 9 (4) ◽  
Author(s):  
Panos Theodosiadis ◽  
Anastasios Konstas ◽  
Ioannis Halkiadakis ◽  
Vasiliki Dimera ◽  
Dimitrios Koufakis ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Ocular Hypertension ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Phase Iii ◽  
Point Estimate ◽  
Eye Drops ◽  
Open Angle ◽  
Parallel Group ◽  
Preservative Free

Background: The aim of this study was to test the non-inferiority of preservative-free (PF) latanoprost 50 μg/mL multi-dose ophthalmic solution versus the marketed benzalkonium chloride (BAK)-preserved latanoprost 50 μg/mL ophthalmic solution in patients with open-angle glaucoma and patients with ocular hypertension. Methods: This was a prospective, national, randomized, multi-center, observer-blind, parallel-group controlled clinical trial. Patients were randomized to receive either PF or BAK-preserved latanoprost once daily for 12 weeks. The primary endpoint was the change in intraocular pressure (IOP) at 8:00 AM in the affected eye between the end of the treatment (week 12) and the baseline (week 0). Secondary measurements were taken at weeks 2 and 6, with IOP being recorded at 8:00 AM, 12:00 PM, and 4:00 PM. Results: A total of 158 patients were included in the per protocol (PP) population (77 in the PF latanoprost treatment arm and 81 patients in the BAK-preserved latanoprost treatment arm). PF latanoprost was non-inferior to BAK-preserved latanoprost in reducing IOP at 8:00 AM in the study eye from the baseline (week 0) to the end of the treatment (week 12). The point estimate of the between-treatment difference was 0.1 mmHg (95% confidence interval: -0.646, 0.847). Mean between-group differences in IOP reduction from the baseline to each of the secondary measurements were also similar between the two treatment arms. The two treatments were well tolerated and had comparable adverse event profiles. Conclusions: PF latanoprost was non-inferior to BAK-preserved latanoprost in reducing IOP in patients with open-angle glaucoma or ocular hypertension. Both treatments were well tolerated.

scholarly journals Non-inferiority evaluation of preservative-free latanoprost/timolol eye drops solution versus preserved latanoprost/timolol eye drops in patients with high intraocular pressure and open-angle glaucoma

2021 ◽  
Vol 9 (4) ◽  
Author(s):  
Panos Theodosiadis ◽  
Anastasios Konstas ◽  
Ioannis Halkiadakis ◽  
Vasiliki Dimera ◽  
Dimitrios Koufakis ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Phase Iii ◽  
Point Estimate ◽  
Eye Drops ◽  
Open Angle ◽  
Local Tolerance ◽  
Safety Parameters ◽  
Preservative Free

Background: This study aimed to evaluate the non-inferiority and safety of a newly developed preservative-free (PF) multi-dose latanoprost/timolol ophthalmic solution, compared with the benzalkonium chloride (BAK)-preserved fixed combination, in patients with open-angle glaucoma and ocular hypertension.Methods: A Phase III randomized multi-center observer-blind parallel-group clinical trial was conducted. A total of 210 adult patients (aged over 18 years) were randomly treated with the PF- or the BAK-preserved latanoprost/timolol solution once daily in the affected eye(s) for 12 weeks. Follow-up visits were scheduled at weeks 2, 6, and 12; intraocular pressure (IOP) was recorded at 8:00 AM, 12:00 PM, and 4:00 PM. The primary efficacy endpoint to prove non-inferiority was the IOP change at 8:00 AM (± 1 hour) from the baseline to the end of treatment (week 12) in the studied eye. Safety parameters were also assessed.Results: In total, 196 patients completed the study. The pressure-lowering effect of the PF eye drops was comparable to that of the preserved formulation at all time points. Latanoprost/timolol PF formulation was non-inferior to the BAK-preserved solution as shown by the change in IOP from day 0 to week 12. The point estimate of the inter-treatment difference was 0.624 mmHg (95% CI: -0.094, 1.341). Both treatments were well-tolerated during the study, and they had similar adverse event profiles.Conclusions: PF-latanoprost/timolol combination was found to be non-inferior to the BAK-preserved formulation based on the efficacy at all times, with similar local tolerance.

scholarly journals Taflotan, the first preservative-free prostaglandin F2α analogue: treatment advantages in primary open-angle glaucoma patients

2016 ◽  
Vol 9 (2) ◽  
pp. 59-68
Author(s):  
Sergey Yu Astakhov ◽  
Natalia V Tkachenko
Keyword(s):  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Tear Film ◽  
Prostaglandin F2α ◽  
Eye Drops ◽  
Open Angle ◽  
Conjunctival Hyperemia ◽  
Prostaglandin F2a ◽  
Negative Effect ◽  
Preservative Free

Over the past 15 years, the negative role of toxic preservatives in the IOP-lowering eye drops solutions used in the treatment of primary open angle glaucoma (POAG) patients has been convincingly proven by many national and foreign experts. Therefore, there is a worldwide tendency to prescribe preferably preservative-free IOP-lowering eye drops nowadays. Taflotan is the world’s first preservative-free prostaglandin F2a analogue. In our study of POAG patients switched to Taflotan from the benzalkonium chloride-preserved latanoprost eye drops, we observed a marked decrease in corneal staining and severity of conjunctival hyperemia, as well as increase of the tear breakup time and corneal epithelium morphology improvement evaluated by confocal tomography. Thus, the drug not only effectively lowers IOP but also produces less negative effect on the tear film and eyeball surface, improving treatment tolerability.

scholarly journals The experience of the first Russian latanoprost 0.005% (Trilactan) use in the treatment of primary open-angle glaucoma

2018 ◽  
Vol 11 (1) ◽  
pp. 67-70
Author(s):  
Alla O Tatarintseva
Keyword(s):  
Intraocular Pressure ◽  
Adverse Events ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Beta Blockers ◽  
Hypotensive Effect ◽  
Open Angle ◽  
Know How ◽  
Treatment Naïve ◽  
Previously Treated

The problem of the reproduced (generic) and original (branded) medications coexistence on the pharmaceutical market is very relevant for Russia. Numerous polls have shown that very few among patients and even doctors clearly understand the differences between original drugs and generics, nor they know how these drugs are produced, and what advantages and weaknesses they have. Aim. This paper covers the study of Trilactan (0.005% latanoprost, Solopharm, Russia) use in patients with different stages of primary open-angle glaucoma, and includes the analysis of the hypotensive effect and adverse events rate. Material and methods. The study included 47 patients divided into 3 groups. The first group included 17 treatment-naïve patients (32 eyes). The second group included 14 patients (28 eyes) previously treated with latanoprost 0.005% once a day in the evening at least for a month. The third group consisted of 16 patients (32 eyes) treated with beta-blockers or carbonic anhydrase inhibitors, in whom the target level of intraocular pressure had not been reached. All patients received 1 drop of Trilactan every evening; the observation lasted for 3 months. Conclusions. The treatment was well tolerated. The intraocular pressure decrease was observed in all cases (p > 0.05). Local and systemic adverse events under Trilactan treatment did not differ from possible side effects typical to the drugs of this pharmacological group in terms of its type and rate. (For citation: Tatarintseva AO. The experience of the first Russian latanoprost 0.005% (Trilactan) use in the treatment of primary open-angle glaucoma. Ophthalmology Journal. 2018;11(1):67-70. doi: 10.17816/OV11167-70).

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