| Autor: |
Topouzis1, F., Melamed2, S., DANESH MEYER3, H., Wells4, A. P., Kozobolis5, V., Wieland6, H., Andrew6, R., Wells6, D., THE INTERNATIONAL TRAVOPROST/TIMOLOL STUDY GROUP University Hospital of Alexandroupolis, Ophthalmic, Department, Kozobolis*, Greece: Vassilios P., George, Maskaleris, Efstathios Detorakis, • II Department of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece: Fotis Topouzis, Eleftherios, Anastasopoulos, Theofanis Pappas, • Ophthalmiatrio Hospital of Athens, Greece: Artemios Kandarakis, John Koutroumanos, • Associate Professor of Ophthalmology, Eye Clinic of the General University Hospital of Ioannina, Greece: Miltiadis Aspiotis, Chrisavgi Pappa, • General Hospital of Nikaia 'AG, Panteleimon, Pireous, ', Greece: Emmanuel Vaikoussis, Thrassyvoulos, Paschalidis, Panagiotis, Bournas, Nikos Kazatzis, • Eye Associates, Sydney, Nsw, Australia: Ivan Goldberg, Stuart, Graham, Paul Healey, • Eye Surgery Associates, East Melbourne VIC, • Suite 8, Australia: Julian Lockhart Rait, Lindfield, Nsw, Australia: Allan Bank*, • Western Sydney Eye Hospital, University, Clinic, Westmead, Hospital, Westmead, Nsw, Healey*, Australia: Paul R., Jonathan, Crowston, Magdalena, Guzowski, Ranier, Covar, Anne, Lee, Jen, Wan, Domit Azar, • Quai des Tanneries 26, • Marktplatz 3, Belgium: Paul Stadion, Eupen, Belgium: François Lizin*, • University Hospital Antwerp, Service of Ophthalmology, Belgium: Veva De Groot, Patrick, Schraepen, Bruno Reyntjens, • University Hospital Ghent, Ghent, Belgium: Anna Maria Kestelyn Stevens, Fien Witters, • Department of Ophthalmology, University of Tartu, Estonia: Pait Teesalu, Imbi, Kuus, Maris Oll, • Ida Tallinna Keskhaigla Silmakliinik, Tallinn, Estonia: Ulle Aamer, Elo, Alas, Marko Pastak, • Hopital Jean Minjoz, Service, D’Ophtalmologie, Besancon, Cedex, Delbosc* • Augenarzt, France: Bernard Y. C., Goeppingen, Germany: Albrecht Gerstenberger*, • Augenarzt, Mannheim, Germany: Peter Jungmann*, • Facharzt fuer Augenheilkunde, Starnberg, Hamacher*, Germany: Ludwig T., Ursula Hellmair •, M. u. e. n. c. h. e. n. e. r. s. t. r. 3., Weilheim, Bayer*, Germany: Andreas U. M., Wolfgang Foerster, • Marktplatz 34 36, Schorndorf, Germany: Thomas Christ*, • Dipartimento di Specialità Medico Chirurgiche dell’Università di Catania, Marta, Azienda Ospedaliera '. S., Emanuele, V., Ferrarotto, Catania, ', Italy: Alfredo Reibaldi, Maurizio, Uva, Antonio, Longo, Daniela Lombardo, • Policlinico San Matteo, Clinica, Oculistica, Pavia, Italy: Fernando Trimarchi, Giovanni, Milano, Antonella, Clemente, Gemma Rossi, M., Ilaria, Scatassi, Francesca Montemurro, • Clinica Oculistica, Università di Torino, Grignolo, Federico, Beatrice, Brogliatti, Rolle, Teresa, Cristina, Favero, Elisabetta, Giacosa, Angela Fornero, • Goldschleger Eye Institute, Sheba Medical Center, Tel, Hashomer, Israel: Shlomo Melamed, Mordehai, Goldenfeld, Hani, Verbin, Zohar, Vilner, Ran, Knaan, Iris Moroz, • Department of Ophthalmology, Carmel Medical Center, Haifa, Israel: Orna Geyer, Eitan Segev, • Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel, Aviv, Israel: Shimon Kurtz, Meira, Neudorfer, Gabi, Shemesh, Shiri Zayit, • Glaucoma Service, Outpatient, Department, Clinical Hospital 'Gailezers, Riga, ', Latvia: Lasma Volksone, Lija Karlsone, • Department of Ophthalmology, Riga Stradins University Hospital, Riga, Latvia: Guna Laganovska, Kristine, Baumane, Ilze Egite, • Eye Clinic, Kaunas University of Medicine, Kaunas, Lithuania: Ingrida Januleviciene, Loreta Kuzmiene, • Eye Institute, Remuera, Auckland, New Zealand: Helen Danesh Meyer*, • Eye Department, Wellington, Hospital, Wellington, Wells*, New Zealand: Anthony P., Andrew, Riley, Anthony, Bedggood, Helen, Long, Nina Ashraff, • Hospital Sao Jose, Servico de Oftalmologia, Lisbon, Abrantes*, Portugal: Pedro A. L., Maria, Reina, Jose Pedro Silva, Joao Ilharco, • Department of Ophthalmology, National University Hospital, Singapore: Paul Tec Kwan Chew, Lennard, Thean, Lim Boon Ang, Joseph, Manuel, Loon Seng Chee, Clement, Tan, Yeong Suet Ming, • Singapore National Eye Centre, Singapore: Steve Kah Leng Seah, Francis, Oen, Rahat, Husain, Hoh Sek Tian, Aung Tin, • Hospital Clinico San Carlos, Madrid, Spain: Julián Garcia Sánchez, Julián García Feijoo, José María Martínez de La Casa, Alfredo Castillo Gómez, • Hospital Universitario Miguel Servet, Consulta de Ojos, Zaragoza, Spain: Francisco Manuel Honrubia López, Vicente Polo Llorens, Luis Pablo Júlvez, Maria Luisa Gómez Martínez, José Manuel Larrosa Póvez, • Fundación Hospital Alcorcón, Servicio de Oftalmología, Universidad Rey Juan Carlos, Alcorcon, Madrid, Spain: Alfonso Arias Puente, Carmen, Carrasco, Maria del Carmen, García, Yolanda, Andrés Alba, • Hospital Universitario La Princesa, Spain: Elena Gurdiel, Emilio, Dorronzoro, Maria Jesús Muniesa, • Department of Ophthalmology, Tri Service General Hospital, Taipei, Taiwan: Da Wen Lu*, • Consultant Ophthalmologist, Arrowe Park Hospital, Wirral, Merseyside, Clearkin*, UK: Louis G., Yogesh, Patwala |
| Rok vydání: |
2007 |
| Předmět: |
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| Zdroj: |
European journal of ophthalmology. 17(2) |
| ISSN: |
1120-6721 |
| Popis: |
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) |
| Databáze: |
OpenAIRE |
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