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

Fotis Topouzis, S. Melamed, H. Danesh-Meyer, A. P. Wells, V. Kozobolis, H. Wieland, R. Andrew, D. Wells, Vassilios P. Kozobolis, George Maskaleris, Efstathios Detorakis, Eleftherios Anastasopoulos, Theofanis Pappas, Artemios Kandarakis, John Koutroumanos, Miltiadis Aspiotis, Chrisavgi Pappa, Emmanuel Vaikoussis, Thrassyvoulos Paschalidis, Panagiotis BournasNikos Kazatzis, Ivan Goldberg, Stuart Graham, Paul Healey, Julian Lockhart Rait, Allan Bank, Paul R. Healey, Jonathan Crowston, Magdalena Guzowski, Ranier Covar, Anne Lee, [No Value] Jen-Wan, Domit Azar, Paul Stadion, François Lizin, Veva De Groot, Patrick Schraepen, Bruno Reyntjens, Anna Maria Kestelyn-Stevens, Fien Witters, Pait Teesalu, Imbi Kuus, Mans Oll, Ulle Aamer, Elo Alas, Marko Pastak, Bernard Y C Delbosc, Albrecht Gerstenberger, Peter Jungmann, Ludwig T. Hamacher, Ursula Hellmair, Andreas U M Bayer, Wolfgang Foerster, Thomas Christ, Alfredo Reibaldi, Maurizio Uva, Antonio Longo, Daniela Lombardo, Fernando Trimarchi, Giovanni Milano, Antonella Clemente, M. Gemma Rossi, Ilaria Scatassi, Francesca Montemurro, Federico M. Grignolo, Beatrice Brogliatti, Teresa Rolle, Cristina Favero, Elisabetta Giacosa, Angela Fornero, Shlomo Melamed, Mordehai Goldenfeld, Hani Verbin, Zohar Vilner, Ran Knaan, Iris Moroz, Orna Geyer, Eitan Segev, Shimon Kurtz, Meira Neudorfer, Gabi Shemesh, Shin Zayit, Lasma Volksone, Lija Karlsone, Guna Laganovska, Kristine Baumane, Ilze Egite, Ingrida Januleviciene, Loreta Kuzmiene, Helen Danesh-Meyer, Anthony P. Wells, Andrew Riley, Anthony Bedggood, Helen Long, Nina Ashraff, Pedro A L Abrantes, Maria Reina, Jose Pedro Silva, Joao Ilharco, Paul Tec Kwan Chew, Lennard Thean, Boon Ang Lim, Joseph Manuel, Seng Chee Loon, Clement Tan, Suet Ming Yeong, Steve Kah Leng Seah, Francis Oen, Rahat Husain, Sek Tian Hoh, Aung Tin, Julián Garcia Sánchez, Julián García Feijoo, José Maria Martínez De La Casa, Alfredo Castillo Gómez, Francisco Manuel Honrubia López, Vicente Polo Llorens, Luis Pablo Júlvez, Maria Luisa Gómez Martínez, José Manuel Larrosa Póvez, Alfonso Arias-Puente, Carmen Carrasco, Maria Del Carmen, Yolanda García, Andrés Alba, Elena Gurdiel, Emilio Dorronzoro, Maria Jesús Muniesa, Da Wen Lu, Louis G. Clearkin, Yogesh Patwala

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)183-190
Number of pages8
JournalEuropean Journal of Ophthalmology
Volume17
Issue number2
Publication statusPublished - Mar 2007

Keywords

  • Glaucoma
  • Intraocular pressure
  • Latanoprost
  • Timolol
  • Travoprost

ASJC Scopus subject areas

  • Ophthalmology

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    Topouzis, F., Melamed, S., Danesh-Meyer, H., Wells, A. P., Kozobolis, V., Wieland, H., Andrew, R., Wells, D., Kozobolis, V. P., Maskaleris, G., Detorakis, E., Anastasopoulos, E., Pappas, T., Kandarakis, A., Koutroumanos, J., Aspiotis, M., Pappa, C., Vaikoussis, E., Paschalidis, T., ... Patwala, Y. (2007). 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. European Journal of Ophthalmology, 17(2), 183-190.