학술논문
A 1-Year Study to Compare the Efficacy and Safety of Once-Daily Travoprost 0.004%/Timolol 0.5% to Once-Daily Latanoprost 0.005%/Timolol 0.5% in Patients with Open-Angle Glaucoma or Ocular Hypertension
Document Type
Article
Author
Topouzis, F.; Melamed, S.; Danesh-meyer, H.; Wells, A.P.; Kozobolis, V.; Wieland, H.; Andrew, R.; Wells, D.; Kozobolis, Vassilios P.; Maskaleris, George; Detorakis, Efstathios; Topouzis, Fotis; Anastasopoulos, Eleftherios; Pappas, Theofanis; Kandarakis, Artemios; Koutroumanos, John; Aspiotis, Miltiadis; Pappa, Chrisavgi; Vaikoussis, Emmanuel; Paschalidis, Thrassyvoulos; Bournas, Panagiotis; Kazatzis, Nikos; Goldberg, Ivan; Graham, Stuart; Healey, Paul; Rait, Julian Lockhart; Bank, Allan; Healey, Paul R.; Crowston, Jonathan; Guzowski, Magdalena; Covar, Ranier; Lee, Anne; Wan, Jen; Azar, Domit; Stadion, Paul; Lizin, François; De Groot, Veva; Schraepen, Patrick; Reyntjens, Bruno; Kestelynstevens, Anna-Maria; Witters, Fien; Teesalu, Pait; Kuus, Imbi; Oll, Maris; Aamer, Ulle; Alas, Elo; Pastak, Marko; Delbosc, Bernard Y.C.; Gerstenberger, Albrecht; Jungmann, Peter; Hamacher, Ludwig T.; Hellmair, Ursula; Bayer, Andreas U.M.; Foerster, Wolfgang; Christ, Thomas; Reibaldi, Alfredo; Uva, Maurizio; Longo, Antonio; Lombardo, Daniela; Trimarchi, Fernando; Milano, Giovanni; Clemente, Antonella; Rossi, M. Gemma; Scatassi, Ilaria; Montemurro, Francesca; Grignolo, Federico M.; Brogliatti, Beatrice; Rolle, Teresa; Favero, Cristina; Giacosa, Elisabetta; Fornero, Angela; Melamed, Sh-lomo; Goldenfeld, Mordehai; Verbin, Hani; Vilner, Zohar; Knaan, Ran; Moroz, Iris; Geyer, Orna; Segev, Eitan; Kurtz, Shimon; Neudorfer, Meira; Shemesh, Gabi; Zayit, Shiri; Volksone, Lasma; Karlsone, Lija; Laganovska, Guna; Baumane, Kristine; Egite, Ilze; Januleviciene, Ingrida; Kuzmiene, Loreta; Danesh-Meyer, Helen; Wells, Anthony P.; Riley, Andrew; Bedggood, Anthony; Long, Helen; Ashraff, Nina; Abrantes, Pedro A.L.; Reina, Maria; Silva, Jose Pedro; Ilharco, Joao; Chew, Paul Tec Kwan; Thean, Lennard; Ang, Lim Boon; Manuel, Joseph; Chee, Loon Seng; Tan, Clement; Ming, Yeong Suet; Seah, Steve Kah Leng; Oen, Francis; Ang, Lim Boon; Husain, Rahat; Tian, Hoh Sek; Tin, Aung; Sánchez Garcia, Julián; Feijoo, Julián García; Martínez de La Casa, José María; Gómez, Alfredo Castillo; López, Francisco Manuel Honrubia; Llorens, Vicente Polo; Júlvez, Luis Pablo; Luisa, Maria; Martínez, Gómez; Manuel, José; Póvez, Larrosa; Arias-Puente, Alfonso; Carrasco, Carmen; del Carmen, Maria; Yolanda, García; Alba, Andrés; Gurdiel, Elena; Dorronzoro, Emilio; Muniesa, Maria Jesús; Lu, Da-Wen; Clearkin, Louis G.; Patwala, Yogesh
Source
European Journal of Ophthalmology; March 2007, Vol. 17 Issue: 2 p183-190, 8p
Subject
Language
ISSN
11206721; 17246016
Abstract
Purpose The objective of the study was to compare the intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004%/timolol 0.5% ophthalmic solution (Trav/Tim) to latanoprost 0.005%/timolol 0.5% ophthalmic solution (Lat/Tim), dosed once daily in the morning, in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).Methods This was a randomized, double-masked, multicenter, parallel group, active-controlled study conducted at 41 sites. At the eligibility visit the patients were randomized (1:1) to the assigned masked medication if they met inclusion/exclusion criteria, and the mean IOP values in the eligible eyes were ≥24 mmHg at 9 AM and ≥21 mmHg at 11 AM and 4 PM. Patients were excluded if the mean IOP in either eye was >36 mmHg. Patients were instructed to administer the assigned medication each morning at 9 AM. During the treatment phase of the study, IOP was measured at 9 AM at week 2, week 6, month 3, and month 9. At the month 6 and month 12 visits, IOP was measured at 9 AM, 11 AM, and 4 PM. Statistical methods included a repeated measures analysis of variance (ANOVA); to test for noninferiority, a 95% confidence interval for the treatment group difference was constructed based on the ANOVA results for each time point at month 12.Results Patients (n=408) with OAG or OH were enrolled at 41 sites. One patient withdrew prior to receiving medication so 207 in the Trav/Tim group and 200 in the Lat/Tim group were evaluable for safety. Baseline demographic characteristics as well as IOP values showed no statistical differences between the two groups. Trav/Tim provided lower mean IOP values than Lat/Tim that were statistically significant at the week 2 9 AM (p=0.0081), month 6 9 AM (p=0.0056), and month 6 11 AM (p=0.0128) time points and at 9 AM time point pooled across all visits (p=0.0235) when mean IOP was 0.6 mmHg lower in the Trav/Tim group. Treatment-related adverse events were mild in both groups. Although hyperemia was reported from a higher percentage of patients in Trav/Tim group, differences in average hyperemia scores between the two groups were not considered clinically relevant.Conclusions Travoprost 0.004%/timolol 0.5% ophthalmic solution produced mean IOP levels that are statistically noninferior to latanoprost 0.005%/timolol 0.5% ophthalmic solution. Furthermore, at 9:00 AM, 24 hours after dosing, IOP was statistically lower for travoprost 0.004%/timolol 0.5% pooled across all visits. Travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution is an effective treatment for reducing IOP and it is safe and well-tolerated in patients with OAG or OH. (Eur J Ophthalmol 2007; 17: 183–90)