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 > or =24 mmHg at 9 AM and > or =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.

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

GRIGNOLO, Federico;ROLLE, Teresa;
2007

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 > or =24 mmHg at 9 AM and > or =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.
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F. TOPOUZIS1; S. MELAMED2; H. DANESH-MEYER3; A.P. WELLS4; V. KOZOBOLIS5; H. WIELAND6; R. ANDREW6; D. WELLS6; THE INTERNATIONAL TRAVOPROST/TIMOLOL STUDY GROUP University Hospital of Alexandroupolis; Ophthalmic Department; Greece: Vassilios P. Kozobolis* (coordinating investigator for the study); 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; Australia: Julian Lockhart Rait* • Suite 8; Lindfield NSW; Australia: Allan Bank* • Western Sydney Eye Hospital; University Clinic; Westmead Hospital; Westmead NSW; Australia: Paul R. Healey*; Jonathan Crowston; Magdalena Guzowski; Ranier Covar; Anne Lee; Jen-Wan; Domit Azar • Quai des Tanneries 26; Belgium: Paul Stadion* • Marktplatz 3; Eupen; Belgium: François Lizin* • University Hospital Antwerp; Service of Ophthalmology; Belgium: Veva De Groot*; Patrick Schraepen; Bruno Reyntjens • University Hospital Ghent; Service of Ophthalmology; 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 (Eye Clinic; East-Tallinn Central Hospital); Tallinn; Estonia: Ulle Aamer*; Elo Alas; Marko Pastak • Hopital Jean Minjoz; Service d’Ophtalmologie; Besancon Cedex; France: Bernard Y.C. Delbosc* • Augenarzt; Goeppingen; Germany: Albrecht Gerstenberger* • Augenarzt; Mannheim; Germany: Peter Jungmann* • Facharzt fuer Augenheilkunde; Starnberg; Germany: Ludwig T. Hamacher*; Ursula Hellmair • Muenchenerstr. 3; Weilheim; Germany: Andreas U.M. Bayer*; Wolfgang Foerster • Marktplatz 34-36; Schorndorf; Germany: Thomas Christ* • Dipartimento di Specialità Medico-Chirurgiche dell’Università di Catania; Azienda Ospedaliera “S. Marta; V. Emanuele; Ferrarotto;” Catania; Italy: Alfredo Reibaldi*; Maurizio Uva; Antonio Longo; Daniela Lombardo • Policlinico San Matteo; Clinica Oculistica; Pavia; Italy: Fernando Trimarchi*; Giovanni Milano*; Antonella Clemente; M. Gemma Rossi; Ilaria Scatassi; Francesca Montemurro • Clinica Oculistica; Università di Torino; Italy: Federico M. Grignolo*; Beatrice Brogliatti; Teresa Rolle; 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; New Zealand: Anthony P. Wells*; Andrew Riley; Anthony Bedggood; Helen Long; Nina Ashraff • Hospital Sao Jose; Servico de Oftalmologia; Lisbon; Portugal: Pedro A.L. Abrantes*; 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; Lim Boon Ang; Rahat Husain; Hoh Sek Tian; Aung Tin • Hospital Clinico San Carlos (Consulta de Glaucoma); 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; Servicio de Oftalmología; Madrid; 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; UK: Louis G. Clearkin*; Yogesh Patwala.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2318/125800
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