scholarly journals A phase III, randomized, clinical, crossover study to evaluate the non-inferiority of an ophthalmic solution of preservative-free latanoprost at 0.005% in patients with primary open-angle glaucoma

2018 ◽  
Vol 4 (3) ◽  
Author(s):  
Victoria E. Sanchez-Castellanos ◽  
Jose A. Paczka ◽  
Francisco Gomez-Aguayo ◽  
Felix Gil-Carrasco ◽  
Curt Hartleben ◽  
...  
Keyword(s):  
Crossover Study ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Phase Iii ◽  
Open Angle ◽  
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 Twenty-four hour efficacy with preservative free tafluprost compared with latanoprost in patients with primary open angle glaucoma or ocular hypertension

2013 ◽  
Vol 97 (12) ◽  
pp. 1510-1515 ◽  
Author(s):  
Anastasios G P Konstas ◽  
Luciano Quaranta ◽  
Andreas Katsanos ◽  
Ivano Riva ◽  
James C Tsai ◽  
...  
Keyword(s):  
Ocular Hypertension ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Open Angle ◽  
Preservative Free

Comparison of Two Fixed Beta-Blocker-Pilocarpine Combinations

1997 ◽  
Vol 7 (4) ◽  
pp. 351-356 ◽  
Author(s):  
◽  
A. M. Bron ◽  
C. P. Garcher ◽  
D. Sirbat ◽  
C. M. Allaire ◽  
...  
Keyword(s):  
Ocular Hypertension ◽  
Beta Blocker ◽  
Statistical Difference ◽  
Primary Open Angle Glaucoma ◽  
Fixed Combination ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Open Angle ◽  
Efficacy And Safety ◽  
Group A

Purpose To compare the efficacy and safety of a newly developed ophthalmic solution containing carteolol 2% and pilocarpine (2% (CBS341A) with a timolol 0.5% and pilocarpine 2% fixed combination. Patients and Methods. A randomized, double-masked, multicenter study was conducted in 209 patients with primary open-angle glaucoma or ocular hypertension, whose intraocular pressure (IOP) was higher than 21 mm Hg on bet-blocker twice a day alone. The test medications were administered twice daily for 4 months. IOP was measured at 9 and 11 a.m. at the beginning of the study (with beta-blocker alone) and after one and four months of treatment. Adverse effects were recorded. Results Both combinations caused a similar, statistically significant decrease in IOP. At four months, in the CBS341A group a 2.4 mm Hg (9%) reduction in IOP was achieved at 9 a.m. and 4.1 mm Hg (17.3%) at 11 a.m. compared with respectively 3 mm Hg (11%) and 4.5 mm Hg (19.5%) in the timolol-pilocarpine group. No statistical difference was observed between the two groups in safety and efficacy. Conclusions The carteolol-pilocarpine combination appears as safe and as effective as the timolol-pilocarpine combination in the medical treatment of primary open-angle glaucoma or ocular hypertension.

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