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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

2007; SAGE Publishing; Volume: 17; Issue: 2 Linguagem: Inglês

10.1177/112067210701700206

1724-6016

Fotis Topouzis, Shlomo Melamed, Helen V. Danesh‐Meyer, Anthony P. Wells, V P Kozobolis, Helga Wieland, Russell Andrew, David T. Wells, Vassilios Kozobolis, George Maskaleris, Εfstathios T. Detorakis, Fotis Topouzis, Eleftherios Anastasopoulos, Theofanis Pappas, Artemios Kandarakis, J. Koutroumanos, Miltiadis Aspiotis, Chrisavgi Pappa, E. Vaikoussis, Thrassyvoulos Paschalidis, P. Bournas, Nikos Kazatzis, Ivan Goldberg, Stuart L. Graham, Paul R. Healey, Julian L Rait, Allan Bank, Paul R. Healey, Jonathan G. Crowston, Magdalena Guzowski, R.A. Covar, Anne Lee, Jen Wan, Domit Azar, P Stadion, François Lizin, Veva De Groot, Patrick Schraepen, Bruno Reyntjens, Anna-Maria Kestelyn-Stevens, Fien Witters, Pait Teesalu, Imbi Kuus, Maris Oll, Ulle Aamer, Elo Alas, Marko Pastak, B Delbosc, Albrecht Gerstenberger, Peter Jungmann, Ludwig T. Hamacher, Ursula Hellmair, Andreas U.M. Bayer, W Foerster, Thomas Christ, A. Reibaldí, Maurizio G. Uva, Antonio Longo, Daniela Lombardo, F Trimarchi, Giovanni Milano, Antonella Clemente, Gemma Caterina Maria Rossi, Ilaria Scatassi, Francesca Montemurro, Federico Grignolo, B. Brogliatti, Teresa Rolle, Cristina Favero, Elisa Giacosa, Angela Fornero, Shlomo Melamed, Mordehai Goldenfeld, Hani Levkovitch Verbin, Zohar Vilner, Ran Knaan, Iris Moroz, Orna Geyer, Eitan Segev, Shimon Kurtz, Meira Neudorfer, Gabi Shemesh, Shiri Zayit, Lāsma Volksone, Lija Karlsone, Guna Laganovska, Kristīne Baumane, Ilze Egite, Ingrida Janulevičienė, Loreta Kuzmienė, Helen V. Danesh‐Meyer, Anthony P. Wells, Andrew F Riley, Anthony Bedggood, Helen Long, Nina Ashraff, Pedro A.L. Abrantes, Maria Reina, José Pedro Silva, J Ilharco, Paul Tec Kwan Chew, Lennard Thean, Lim Boon Ang, Joseph Manuel, Loon Seng Chee, Clement Tan, Yeong Suet Ming, Steve K.L. Seah, Francis T.S. Oen, Lim Boon Ang, Rahat Husain, Hoh Sek Tian, Tin Aung, Julián Sánchez Garcia, J. García–Sánchez, J.M. Martínez-de-la-Casa, Alfredo Castillo Gómez, Francisco Manuel Honrubia López, Vicente Polo, Luís E. Pablo, Maria Luisa, Gómez Martínez, José Manuel, Larrosa Póvez, Alfonso Arias Puente, C. Carrasco, María del Carmen, García Yolanda, Andrés Alba, Elena Gurdiel, E. Dorronzoro, María Jesús Muniesa, Da‐Wen Lu, L G Clearkin, Yogesh J Patwala,

Retinal Diseases and Treatments

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)