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 Bournas & 111 others Nikos 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

38 Citations (Scopus)

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

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latanoprost
Timolol
Ocular Hypertension
Open Angle Glaucoma
Ophthalmic Solutions
Intraocular Pressure
Safety
Hyperemia
Travoprost
Analysis of Variance

Keywords

  • Glaucoma
  • Intraocular pressure
  • Latanoprost
  • Timolol
  • Travoprost

ASJC Scopus subject areas

  • Ophthalmology

Cite this

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

In: European Journal of Ophthalmology, Vol. 17, No. 2, 03.2007, p. 183-190.

Research output: Contribution to journalArticle

Topouzis, F, Melamed, S, Danesh-Meyer, H, Wells, AP, Kozobolis, V, Wieland, H, Andrew, R, Wells, D, Kozobolis, VP, Maskaleris, G, Detorakis, E, Anastasopoulos, E, Pappas, T, Kandarakis, A, Koutroumanos, J, Aspiotis, M, Pappa, C, Vaikoussis, E, Paschalidis, T, Bournas, P, Kazatzis, N, Goldberg, I, Graham, S, Healey, P, Rait, JL, Bank, A, Healey, PR, Crowston, J, Guzowski, M, Covar, R, Lee, A, Jen-Wan, NV, Azar, D, Stadion, P, Lizin, F, De Groot, V, Schraepen, P, Reyntjens, B, Kestelyn-Stevens, AM, Witters, F, Teesalu, P, Kuus, I, Oll, M, Aamer, U, Alas, E, Pastak, M, Delbosc, BYC, Gerstenberger, A, Jungmann, P, Hamacher, LT, Hellmair, U, Bayer, AUM, Foerster, W, Christ, T, Reibaldi, A, Uva, M, Longo, A, Lombardo, D, Trimarchi, F, Milano, G, Clemente, A, Rossi, MG, Scatassi, I, Montemurro, F, Grignolo, FM, Brogliatti, B, Rolle, T, Favero, C, Giacosa, E, Fornero, A, Melamed, S, Goldenfeld, M, Verbin, H, Vilner, Z, Knaan, R, Moroz, I, Geyer, O, Segev, E, Kurtz, S, Neudorfer, M, Shemesh, G, Zayit, S, Volksone, L, Karlsone, L, Laganovska, G, Baumane, K, Egite, I, Januleviciene, I, Kuzmiene, L, Danesh-Meyer, H, Wells, AP, Riley, A, Bedggood, A, Long, H, Ashraff, N, Abrantes, PAL, Reina, M, Silva, JP, Ilharco, J, Chew, PTK, Thean, L, Lim, BA, Manuel, J, Loon, SC, Tan, C, Yeong, SM, Seah, SKL, Oen, F, Husain, R, Hoh, ST, Tin, A, Sánchez, JG, Feijoo, JG, De La Casa, JMM, Gómez, AC, López, FMH, Llorens, VP, Júlvez, LP, Martínez, MLG, Póvez, JML, Arias-Puente, A, Carrasco, C, Del Carmen, M, García, Y, Alba, A, Gurdiel, E, Dorronzoro, E, Muniesa, MJ, Lu, DW, Clearkin, LG & 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, vol. 17, no. 2, pp. 183-190.
Topouzis, Fotis ; Melamed, S. ; Danesh-Meyer, H. ; Wells, A. P. ; Kozobolis, V. ; Wieland, H. ; Andrew, R. ; Wells, D. ; Kozobolis, Vassilios P. ; Maskaleris, George ; Detorakis, Efstathios ; Anastasopoulos, Eleftherios ; Pappas, Theofanis ; Kandarakis, Artemios ; Koutroumanos, John ; Aspiotis, Miltiadis ; Pappa, Chrisavgi ; Vaikoussis, Emmanuel ; Paschalidis, Thrassyvoulos ; Bournas, Panagiotis ; Kazatzis, Nikos ; Goldberg, Ivan ; Graham, Stuart ; Healey, Paul ; Rait, Julian Lockhart ; Bank, Allan ; Healey, Paul R. ; Crowston, Jonathan ; Guzowski, Magdalena ; Covar, Ranier ; Lee, Anne ; Jen-Wan, [No Value] ; Azar, Domit ; Stadion, Paul ; Lizin, François ; De Groot, Veva ; Schraepen, Patrick ; Reyntjens, Bruno ; Kestelyn-Stevens, Anna Maria ; Witters, Fien ; Teesalu, Pait ; Kuus, Imbi ; Oll, Mans ; Aamer, Ulle ; Alas, Elo ; Pastak, Marko ; Delbosc, Bernard Y C ; Gerstenberger, Albrecht ; Jungmann, Peter ; Hamacher, Ludwig T. ; Hellmair, Ursula ; Bayer, Andreas U M ; Foerster, Wolfgang ; Christ, Thomas ; Reibaldi, Alfredo ; Uva, Maurizio ; Longo, Antonio ; Lombardo, Daniela ; Trimarchi, Fernando ; Milano, Giovanni ; Clemente, Antonella ; Rossi, M. Gemma ; Scatassi, Ilaria ; Montemurro, Francesca ; Grignolo, Federico M. ; Brogliatti, Beatrice ; Rolle, Teresa ; Favero, Cristina ; Giacosa, Elisabetta ; Fornero, Angela ; Melamed, Shlomo ; Goldenfeld, Mordehai ; Verbin, Hani ; Vilner, Zohar ; Knaan, Ran ; Moroz, Iris ; Geyer, Orna ; Segev, Eitan ; Kurtz, Shimon ; Neudorfer, Meira ; Shemesh, Gabi ; Zayit, Shin ; Volksone, Lasma ; Karlsone, Lija ; Laganovska, Guna ; Baumane, Kristine ; Egite, Ilze ; Januleviciene, Ingrida ; Kuzmiene, Loreta ; Danesh-Meyer, Helen ; Wells, Anthony P. ; Riley, Andrew ; Bedggood, Anthony ; Long, Helen ; Ashraff, Nina ; Abrantes, Pedro A L ; Reina, Maria ; Silva, Jose Pedro ; Ilharco, Joao ; Chew, Paul Tec Kwan ; Thean, Lennard ; Lim, Boon Ang ; Manuel, Joseph ; Loon, Seng Chee ; Tan, Clement ; Yeong, Suet Ming ; Seah, Steve Kah Leng ; Oen, Francis ; Husain, Rahat ; Hoh, Sek Tian ; Tin, Aung ; Sánchez, Julián Garcia ; Feijoo, Julián García ; De La Casa, José Maria Martínez ; Gómez, Alfredo Castillo ; López, Francisco Manuel Honrubia ; Llorens, Vicente Polo ; Júlvez, Luis Pablo ; Martínez, Maria Luisa Gómez ; Póvez, José Manuel Larrosa ; Arias-Puente, Alfonso ; Carrasco, Carmen ; Del Carmen, Maria ; García, Yolanda ; Alba, Andrés ; Gurdiel, Elena ; Dorronzoro, Emilio ; Muniesa, Maria Jesús ; Lu, Da Wen ; Clearkin, Louis G. ; Patwala, Yogesh. / 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. In: European Journal of Ophthalmology. 2007 ; Vol. 17, No. 2. pp. 183-190.
@article{d92818b9aeba4cd7ba56bffeed572ff5,
title = "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",
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.",
keywords = "Glaucoma, Intraocular pressure, Latanoprost, Timolol, Travoprost",
author = "Fotis Topouzis and S. Melamed and H. Danesh-Meyer and Wells, {A. P.} and V. Kozobolis and H. Wieland and R. Andrew and D. Wells and Kozobolis, {Vassilios P.} and George Maskaleris and Efstathios Detorakis and Eleftherios Anastasopoulos and Theofanis Pappas and Artemios Kandarakis and John Koutroumanos and Miltiadis Aspiotis and Chrisavgi Pappa and Emmanuel Vaikoussis and Thrassyvoulos Paschalidis and Panagiotis Bournas and Nikos Kazatzis and Ivan Goldberg and Stuart Graham and Paul Healey and Rait, {Julian Lockhart} and Allan Bank and Healey, {Paul R.} and Jonathan Crowston and Magdalena Guzowski and Ranier Covar and Anne Lee and Jen-Wan, {[No Value]} and Domit Azar and Paul Stadion and Fran{\cc}ois Lizin and {De Groot}, Veva and Patrick Schraepen and Bruno Reyntjens and Kestelyn-Stevens, {Anna Maria} and Fien Witters and Pait Teesalu and Imbi Kuus and Mans Oll and Ulle Aamer and Elo Alas and Marko Pastak and Delbosc, {Bernard Y C} and Albrecht Gerstenberger and Peter Jungmann and Hamacher, {Ludwig T.} and Ursula Hellmair and Bayer, {Andreas U M} and Wolfgang Foerster and Thomas Christ and Alfredo Reibaldi and Maurizio Uva and Antonio Longo and Daniela Lombardo and Fernando Trimarchi and Giovanni Milano and Antonella Clemente and Rossi, {M. Gemma} and Ilaria Scatassi and Francesca Montemurro and Grignolo, {Federico M.} and Beatrice Brogliatti and Teresa Rolle and Cristina Favero and Elisabetta Giacosa and Angela Fornero and Shlomo Melamed and Mordehai Goldenfeld and Hani Verbin and Zohar Vilner and Ran Knaan and Iris Moroz and Orna Geyer and Eitan Segev and Shimon Kurtz and Meira Neudorfer and Gabi Shemesh and Shin Zayit and Lasma Volksone and Lija Karlsone and Guna Laganovska and Kristine Baumane and Ilze Egite and Ingrida Januleviciene and Loreta Kuzmiene and Helen Danesh-Meyer and Wells, {Anthony P.} and Andrew Riley and Anthony Bedggood and Helen Long and Nina Ashraff and Abrantes, {Pedro A L} and Maria Reina and Silva, {Jose Pedro} and Joao Ilharco and Chew, {Paul Tec Kwan} and Lennard Thean and Lim, {Boon Ang} and Joseph Manuel and Loon, {Seng Chee} and Clement Tan and Yeong, {Suet Ming} and Seah, {Steve Kah Leng} and Francis Oen and Rahat Husain and Hoh, {Sek Tian} and Aung Tin and S{\'a}nchez, {Juli{\'a}n Garcia} and Feijoo, {Juli{\'a}n Garc{\'i}a} and {De La Casa}, {Jos{\'e} Maria Mart{\'i}nez} and G{\'o}mez, {Alfredo Castillo} and L{\'o}pez, {Francisco Manuel Honrubia} and Llorens, {Vicente Polo} and J{\'u}lvez, {Luis Pablo} and Mart{\'i}nez, {Maria Luisa G{\'o}mez} and P{\'o}vez, {Jos{\'e} Manuel Larrosa} and Alfonso Arias-Puente and Carmen Carrasco and {Del Carmen}, Maria and Yolanda Garc{\'i}a and Andr{\'e}s Alba and Elena Gurdiel and Emilio Dorronzoro and Muniesa, {Maria Jes{\'u}s} and Lu, {Da Wen} and Clearkin, {Louis G.} and Yogesh Patwala",
year = "2007",
month = "3",
language = "English",
volume = "17",
pages = "183--190",
journal = "European Journal of Ophthalmology",
issn = "1120-6721",
publisher = "Wichtig Publishing",
number = "2",

}

TY - JOUR

T1 - 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

AU - Topouzis, Fotis

AU - Melamed, S.

AU - Danesh-Meyer, H.

AU - Wells, A. P.

AU - Kozobolis, V.

AU - Wieland, H.

AU - Andrew, R.

AU - Wells, D.

AU - Kozobolis, Vassilios P.

AU - Maskaleris, George

AU - Detorakis, Efstathios

AU - Anastasopoulos, Eleftherios

AU - Pappas, Theofanis

AU - Kandarakis, Artemios

AU - Koutroumanos, John

AU - Aspiotis, Miltiadis

AU - Pappa, Chrisavgi

AU - Vaikoussis, Emmanuel

AU - Paschalidis, Thrassyvoulos

AU - Bournas, Panagiotis

AU - Kazatzis, Nikos

AU - Goldberg, Ivan

AU - Graham, Stuart

AU - Healey, Paul

AU - Rait, Julian Lockhart

AU - Bank, Allan

AU - Healey, Paul R.

AU - Crowston, Jonathan

AU - Guzowski, Magdalena

AU - Covar, Ranier

AU - Lee, Anne

AU - Jen-Wan, [No Value]

AU - Azar, Domit

AU - Stadion, Paul

AU - Lizin, François

AU - De Groot, Veva

AU - Schraepen, Patrick

AU - Reyntjens, Bruno

AU - Kestelyn-Stevens, Anna Maria

AU - Witters, Fien

AU - Teesalu, Pait

AU - Kuus, Imbi

AU - Oll, Mans

AU - Aamer, Ulle

AU - Alas, Elo

AU - Pastak, Marko

AU - Delbosc, Bernard Y C

AU - Gerstenberger, Albrecht

AU - Jungmann, Peter

AU - Hamacher, Ludwig T.

AU - Hellmair, Ursula

AU - Bayer, Andreas U M

AU - Foerster, Wolfgang

AU - Christ, Thomas

AU - Reibaldi, Alfredo

AU - Uva, Maurizio

AU - Longo, Antonio

AU - Lombardo, Daniela

AU - Trimarchi, Fernando

AU - Milano, Giovanni

AU - Clemente, Antonella

AU - Rossi, M. Gemma

AU - Scatassi, Ilaria

AU - Montemurro, Francesca

AU - Grignolo, Federico M.

AU - Brogliatti, Beatrice

AU - Rolle, Teresa

AU - Favero, Cristina

AU - Giacosa, Elisabetta

AU - Fornero, Angela

AU - Melamed, Shlomo

AU - Goldenfeld, Mordehai

AU - Verbin, Hani

AU - Vilner, Zohar

AU - Knaan, Ran

AU - Moroz, Iris

AU - Geyer, Orna

AU - Segev, Eitan

AU - Kurtz, Shimon

AU - Neudorfer, Meira

AU - Shemesh, Gabi

AU - Zayit, Shin

AU - Volksone, Lasma

AU - Karlsone, Lija

AU - Laganovska, Guna

AU - Baumane, Kristine

AU - Egite, Ilze

AU - Januleviciene, Ingrida

AU - Kuzmiene, Loreta

AU - Danesh-Meyer, Helen

AU - Wells, Anthony P.

AU - Riley, Andrew

AU - Bedggood, Anthony

AU - Long, Helen

AU - Ashraff, Nina

AU - Abrantes, Pedro A L

AU - Reina, Maria

AU - Silva, Jose Pedro

AU - Ilharco, Joao

AU - Chew, Paul Tec Kwan

AU - Thean, Lennard

AU - Lim, Boon Ang

AU - Manuel, Joseph

AU - Loon, Seng Chee

AU - Tan, Clement

AU - Yeong, Suet Ming

AU - Seah, Steve Kah Leng

AU - Oen, Francis

AU - Husain, Rahat

AU - Hoh, Sek Tian

AU - Tin, Aung

AU - Sánchez, Julián Garcia

AU - Feijoo, Julián García

AU - De La Casa, José Maria Martínez

AU - Gómez, Alfredo Castillo

AU - López, Francisco Manuel Honrubia

AU - Llorens, Vicente Polo

AU - Júlvez, Luis Pablo

AU - Martínez, Maria Luisa Gómez

AU - Póvez, José Manuel Larrosa

AU - Arias-Puente, Alfonso

AU - Carrasco, Carmen

AU - Del Carmen, Maria

AU - García, Yolanda

AU - Alba, Andrés

AU - Gurdiel, Elena

AU - Dorronzoro, Emilio

AU - Muniesa, Maria Jesús

AU - Lu, Da Wen

AU - Clearkin, Louis G.

AU - Patwala, Yogesh

PY - 2007/3

Y1 - 2007/3

N2 - 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.

AB - 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.

KW - Glaucoma

KW - Intraocular pressure

KW - Latanoprost

KW - Timolol

KW - Travoprost

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M3 - Article

VL - 17

SP - 183

EP - 190

JO - European Journal of Ophthalmology

JF - European Journal of Ophthalmology

SN - 1120-6721

IS - 2

ER -