Efficacy, Safety, and Tolerability of Preservative-Free Fixed Combination of Tafluprost 0.0015%/Timolol 0.5% Versus Concomitant Use of the Ingredients

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F14%3AN0000033" target="_blank" >RIV/00064173:_____/14:N0000033 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1089/jop.2013.0229" target="_blank" >http://dx.doi.org/10.1089/jop.2013.0229</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1089/jop.2013.0229" target="_blank" >10.1089/jop.2013.0229</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy, Safety, and Tolerability of Preservative-Free Fixed Combination of Tafluprost 0.0015%/Timolol 0.5% Versus Concomitant Use of the Ingredients

Popis výsledku v původním jazyce

Purpose: To compare efficacy, safety, and tolerability of the preservative-free fixed combination (FC) and non-fixed combination (NFC) of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. Methods: This 6-month, prospective, randomized, double-masked, active-controlled, parallel group, multicenter phase III study was performed in patients with ocular hypertension and open-angle glaucoma with untreated intraocular pressure (IOP) >= 23 and <= 36 mmHg at baseline. Results: Four hundred patients washed out from IOP-lowering medication were randomized, 201 received the FC, and 199 received the NFC. Mean time-wise IOP decreases from baseline ranged from -7.3 to -9.1 mmHg (29.6%-34.6%) in the FC and from -7.5 to -9.4 mmHg (30.7%-36.0%) in the NFC arm [per-protocol (PP) dataset, P < 0.0001 compared with baseline for both groups]. At month 6, the estimated overall treatment difference (FC-NFC) was 0.308 mmHg (PP dataset, 95% confidence interval from -0.194 to 0.810 mmHg). An IOP decrease >= 30% was achieved in 58.3% and 66.9% of the patients in the FC and NFC groups, respectively (PP dataset; P = 0.105); an IOP decrease >= 35% was achieved in 36.6% and 43.1% of patients in the FC and NFC groups, respectively (PP dataset; P = 0.297). Patients with ocular adverse events were evenly distributed in both groups. The most common side effect, conjunctival/ocular hyperemia was found in 8% and 5% of patients in the FC and NFC arms, respectively. Conclusions: All measures of IOP reduction for FC of preservative-free tafluprost/timolol were statistically and clinically significant and non-inferior to those of the NFC, throughout the 6-month study period.

Název v anglickém jazyce

Efficacy, Safety, and Tolerability of Preservative-Free Fixed Combination of Tafluprost 0.0015%/Timolol 0.5% Versus Concomitant Use of the Ingredients

Popis výsledku anglicky

Purpose: To compare efficacy, safety, and tolerability of the preservative-free fixed combination (FC) and non-fixed combination (NFC) of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. Methods: This 6-month, prospective, randomized, double-masked, active-controlled, parallel group, multicenter phase III study was performed in patients with ocular hypertension and open-angle glaucoma with untreated intraocular pressure (IOP) >= 23 and <= 36 mmHg at baseline. Results: Four hundred patients washed out from IOP-lowering medication were randomized, 201 received the FC, and 199 received the NFC. Mean time-wise IOP decreases from baseline ranged from -7.3 to -9.1 mmHg (29.6%-34.6%) in the FC and from -7.5 to -9.4 mmHg (30.7%-36.0%) in the NFC arm [per-protocol (PP) dataset, P < 0.0001 compared with baseline for both groups]. At month 6, the estimated overall treatment difference (FC-NFC) was 0.308 mmHg (PP dataset, 95% confidence interval from -0.194 to 0.810 mmHg). An IOP decrease >= 30% was achieved in 58.3% and 66.9% of the patients in the FC and NFC groups, respectively (PP dataset; P = 0.105); an IOP decrease >= 35% was achieved in 36.6% and 43.1% of patients in the FC and NFC groups, respectively (PP dataset; P = 0.297). Patients with ocular adverse events were evenly distributed in both groups. The most common side effect, conjunctival/ocular hyperemia was found in 8% and 5% of patients in the FC and NFC arms, respectively. Conclusions: All measures of IOP reduction for FC of preservative-free tafluprost/timolol were statistically and clinically significant and non-inferior to those of the NFC, throughout the 6-month study period.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FF - ORL, oftalmologie, stomatologie

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2014

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Ocular Pharmacology and Therapeutics

ISSN

1080-7683

e-ISSN

—

Svazek periodika

30

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

468-475

Kód UT WoS článku

000338922600004

EID výsledku v databázi Scopus

2-s2.0-84903696826