Phase III, 24-month study investigating the efficacy and safety of tafluprost vs latanoprost in patients with open-angle glaucoma or ocular hypertension

2008 ◽  
Vol 86 ◽  
pp. 0-0
Author(s):  
HMT UUSITALO ◽  
LE PILLUNAT ◽  
C BAUDOUIN ◽  
C TRAVERSO ◽  
A BERGSTRÖM ◽  
...  
Keyword(s):  
Ocular Hypertension ◽  
Open Angle Glaucoma ◽  
Phase Iii ◽  
Open Angle ◽  
Efficacy And Safety

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.

Efficacy and Safety of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution Once Daily for Open-Angle Glaucoma or Ocular Hypertension

2005 ◽  
Vol 140 (2) ◽  
pp. 242.e1-242.e11 ◽  
Author(s):  
Joel S. Schuman ◽  
Gregory J. Katz ◽  
Richard A. Lewis ◽  
J. Charles Henry ◽  
Sushanta Mallick ◽  
...  
Keyword(s):  
Ocular Hypertension ◽  
Fixed Combination ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Open Angle ◽  
Efficacy And Safety ◽  
Once Daily
Sign in / Sign up

Export Citation Format

Share Document