scholarly journals Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension

2019 ◽  
Vol 28 (6) ◽  
pp. 498-506
Author(s):  
Florent Aptel ◽  
Norbert Pfeiffer ◽  
Stefanie Schmickler ◽  
Jonathan Clarke ◽  
Cosme Lavín-Dapena ◽  
...  
Keyword(s):  
Ocular Hypertension ◽  
Fixed Combination ◽  
Open Angle Glaucoma ◽  
Eye Drops ◽  
Open Angle ◽  
Preservative Free

scholarly journals A Comparative Analysis of the Efficacy and Safety of fixed Combinations of Latanoprost/Timolol vs Dorzolamide/Timolol in Primary Open Angle Glaucoma or Ocular Hypertension

2012 ◽  
Vol 46 (4) ◽  
pp. 172-176
Author(s):  
Sukhsagar Ratol ◽  
Rani Walia ◽  
Mridu Chaudhry
Keyword(s):  
Ocular Hypertension ◽  
Primary Open Angle Glaucoma ◽  
Fixed Combination ◽  
Open Angle Glaucoma ◽  
Eye Drops ◽  
Open Angle ◽  
Once Daily ◽  
Group 2 ◽  
Diurnal Iop ◽  
Group 1

ABSTRACT Background Glaucoma is a leading cause of irreversible blindness. The fundamental problem in medical management of glaucoma is of patient compliance. An ideal drug or a drug combination is needed to slow the progression of this majorly symptomless disease. Aim To compare the efficacy and tolerability of the fixed combination latanoprost and timolol instilled once daily in the evening vs fixed combination of dorzolamide and timolol instilled twice daily in primary open angle glaucoma or ocular hypertension. Materials and methods A 12-week, randomized, open, parallel group study including 50 patients with primary open angle glaucoma or ocular hypertension was conducted at a tertiary care hospital. Patients were randomized to group 1, (fixed combination (FC) latanoprost and timolol eye drops, once daily in evening) and group 2, (FC dorzolamide and timolol eye drops, twice daily). At baseline, 2, 4 and 12 weeks, IOP was recorded at 9 AM and 12 noon. The difference in IOP reduction in two treatment groups from baseline to 12 weeks was the main outcome measure. Results Mean diurnal IOP was similar at baseline for both groups. Mean reduction in IOP from baseline to 12 weeks was 9.92 mm Hg (p = 0.001) in group 1 and 9.22 (p = 0.001) in group 2. The reduction in IOP in both groups 1 and 2 was statistically significant at all time intervals. There was a statistically significant advantage for group 1 at 12 weeks for both time readings (p = 0.013 and 0.002 respectively) as compared to group 2. Conclusion The fixed combination of latanoprost and timolol was more effective than that of dorzolamide and timolol in reducing mean diurnal IOP and both treatments were well tolerated. To confirm further such studies are required. How to cite this article Ratol S, Walia R, Chaudhry M. A Comparative Analysis of the Efficacy and Safety of fixed Combinations of Latanoprost/Timolol vs Dorzolamide/Timolol in Primary Open Angle Glaucoma or Ocular Hypertension. J Postgrad Med Edu Res 2012;46(4):172-176.

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 Efficacy and safety of newly developed preservative-free latanoprost 0.005% eye drops versus preserved latanoprost 0.005% in open angle glaucoma and ocular hypertension: 12-week results of a randomized, multicenter, controlled phase III trial

2021 ◽  
Vol 14 (10) ◽  
pp. 1539-1547
Author(s):  
Joon Mo Kim ◽  
◽  
Ji Woong Lee ◽  
Haksu Kyung ◽  
Seungsoo Rho ◽  
...  
Keyword(s):  
Ocular Hypertension ◽  
Open Angle Glaucoma ◽  
Similar Efficacy ◽  
Phase Iii ◽  
Eye Drops ◽  
Open Angle ◽  
Phase Iii Trial ◽  
Diurnal Iop ◽  
Preservative Free

AIM: To evaluate the therapeutic efficacy, safety and tolerability of newly developed preservative-free (PF) latanoprost generic [TJO-002] and compare it with benzalkonium chloride (BAK)-preserved latanoprost [Xalatan®] in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). METHODS: Included patients were aged ≥19y with POAG/OHT. After a washout period, patients with IOP 21-35 mm Hg at 9 a.m. were enrolled. After a full ophthalmic and glaucoma examination, 144 patients with POAG and OHT participated in this study. Subjects were randomly assigned either PF latanoprost (74 eyes) or BAK-preserved latanoprost (70 eyes). All subjects were examined at 4, 8, and 12wk after first administration. At each follow-up visit, IOP was measured at 9 a.m. and 5 p.m. and compliance was assessed. Throughout the study, all adverse events were recorded and monitored by the masked investigators who measured IOP. RESULTS: Both groups showed a statistically significant decrease of average diurnal IOP at 12wk compared to baseline (-7.21±3.10 mm Hg in the PF latanoprost group and -7.02±3.17 mm Hg in the BAK latanoprost group, both P<0.0001). There was no statistically significant diurnal IOP variation between the groups. In terms of tolerability, pruritus, burning/stinging, and sticky eye sensation, severity was significantly lower in the PF latanoprost group than in the BAK latanoprost group (P<0.05). CONCLUSION: PF latanoprost has at least similar efficacy in terms of IOP reduction and better tolerability compared with BAK latanoprost.

scholarly journals Treatment of Primary Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost-Timolol Fixed-Dose Combination Versus Preservative-Free Latanoprost-Timolol Fixed-Dose Combination Therapy: Real-World Experience

2021 ◽  
Author(s):  
Ulrich Thelen
Keyword(s):  
Combination Therapy ◽  
Ocular Hypertension ◽  
Primary Open Angle Glaucoma ◽  
Fixed Combination ◽  
Open Angle Glaucoma ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Open Angle ◽  
Dose Combination ◽  
Preservative Free

Abstract Background: To evaluate the effect of an "escalation" of topical glaucoma therapy by switching form prostaglandin monotherapy to two different prostaglandin-timolol fixed combinations.Methods: 30 patients (60 eyes) with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) were initially treated with the prostaglandin analog latanoprost in a preservative-free formulation. 15 patients each were for 6 months - because of IOP levels considered still too high - treated with preservative-free tafluprost/timolol fixed-dose combination or preservative-free latanoprost/timolol fixed-dose combination therapy. Results: Six months after switching from latanopost monotherapy to preservative-free prostaglandin-timolol combinations, patients being treated with the latanoprost-timolol fixed combination had a mean IOP reduction by 4.16 mm Hg and those treated with the tafluprost-timolol fixed combination a mean IOP reduction by 5.38 mm Hg. Regarding safety and tolerability, there were no issues in the tafluprost-timolol group.Conclusions: Switching from prostaglandin monotherapy to a prostaglandin-timolol fixed combination led to a sufficient IOP lowering in our group of patients. Tolerability of, and satisfaction with, the fixed combination therapies was high.

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