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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
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*;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;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 • M.u.e.n.c.h.e.n.e.r.s.t.r. 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;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;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;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
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.
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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simulazione ASN
Il report seguente simula gli indicatori relativi alla produzione scientifica in relazione alle soglie ASN 2018-2020 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione.
La simulazione si basa sui dati IRIS e presenta gli indicatori calcolati alla data indicata sul report. Si ricorda che in sede di domanda ASN presso il MIUR gli indicatori saranno invece calcolati a partire dal 1° gennaio rispettivamente del quinto/decimo/quindicesimo anno precedente la scadenza del quadrimestre di presentazione della domanda (art 2 del DM 598/2018).
In questa simulazione pertanto il valore degli indicatori potrà differire da quello conteggiato all’atto della domanda ASN effettuata presso il MIUR a seguito di:
Correzioni imputabili a eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori.
Presenza di eventuali errori di catalogazione e/o dati mancanti in IRIS
Variabilità nel tempo dei valori citazionali (per i settori bibliometrici)
Variabilità della finestra temporale considerata in funzione della sessione di domanda ASN a cui si partecipa.
La presente simulazione è stata realizzata sulla base delle regole riportate nel DM 598/2018 e dell'allegata Tabella A e delle specifiche definite all'interno del Focus Group Cineca relativo al modulo IRIS ER. Il Cineca non si assume alcuna responsabilità in merito all'uso che il diretto interessato o terzi faranno della simulazione.