Please use this identifier to cite or link to this item: https://scholarbank.nus.edu.sg/handle/10635/129793
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
Authors: 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.
Bournas, P.
Kazatzis, N.
Goldberg, I.
Graham, S.
Healey, P.
Rait, J.L.
Bank, A.
Healey, P.R.
Crowston, J.
Guzowski, M.
Covar, R.
Lee, A.
Jen-Wan
Azar, D.
Stadion, P.
Lizin, F.
De Groot, V.
Schraepen, P.
Reyntjens, B.
Kestelyn-Stevens, A.-M.
Witters, F.
Teesalu, P.
Kuus, I.
Oll, M.
Aamer, U.
Alas, E.
Pastak, M.
Delbosc, B.Y.C.
Gerstenberger, A.
Jungmann, P.
Hamacher, L.T.
Hellmair, U.
Bayer, A.U.M.
Foerster, W.
Christ, T.
Reibaldi, A.
Uva, M.
Longo, A.
Lombardo, D.
Trimarchi, F.
Milano, G.
Clemente, A.
Rossi, M.G.
Scatassi, I.
Montemurro, F.
Grignolo, F.M.
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, A.P.
Riley, A.
Bedggood, A.
Long, H.
Ashraff, N.
Abrantes, P.A.L.
Reina, M.
Silva, J.P.
Ilharco, J.
Chew, P.T.K. 
Thean, L.
Lim, B.A.
Manuel, J.
Loon, S.C.
Tan, C.
Yeong, S.M.
Seah, S.K.L.
Oen, F.
Husain, R.
Hoh, S.T.
Tin, A.
Sánchez, J.G.
Feijoo, J.G.
De La Casa, J.M.M.
Gómez, A.C.
López, F.M.H.
Llorens, V.P.
Júlvez, L.P.
Martínez, M.L.G.
Póvez, J.M.L.
Arias-Puente, A.
Carrasco, C.
Del Carmen, M.
García, Y.
Alba, A.
Gurdiel, E.
Dorronzoro, E.
Muniesa, M.J.
Lu, D.-W.
Clearkin, L.G.
Patwala, Y.
Keywords: Glaucoma
Intraocular pressure
Latanoprost
Timolol
Travoprost
Issue Date: Mar-2007
Citation: 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., Bournas, P., Kazatzis, N., Goldberg, I., Graham, S., Healey, P., Rait, J.L., Bank, A., Healey, P.R., Crowston, J., Guzowski, M., Covar, R., Lee, A., Jen-Wan, Azar, D., Stadion, P., Lizin, F., De Groot, V., Schraepen, P., Reyntjens, B., Kestelyn-Stevens, A.-M., Witters, F., Teesalu, P., Kuus, I., Oll, M., Aamer, U., Alas, E., Pastak, M., Delbosc, B.Y.C., Gerstenberger, A., Jungmann, P., Hamacher, L.T., Hellmair, U., Bayer, A.U.M., Foerster, W., Christ, T., Reibaldi, A., Uva, M., Longo, A., Lombardo, D., Trimarchi, F., Milano, G., Clemente, A., Rossi, M.G., Scatassi, I., Montemurro, F., Grignolo, F.M., 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, A.P., Riley, A., Bedggood, A., Long, H., Ashraff, N., Abrantes, P.A.L., Reina, M., Silva, J.P., Ilharco, J., Chew, P.T.K., Thean, L., Lim, B.A., Manuel, J., Loon, S.C., Tan, C., Yeong, S.M., Seah, S.K.L., Oen, F., Husain, R., Hoh, S.T., Tin, A., Sánchez, J.G., Feijoo, J.G., De La Casa, J.M.M., Gómez, A.C., López, F.M.H., Llorens, V.P., Júlvez, L.P., Martínez, M.L.G., Póvez, J.M.L., Arias-Puente, A., Carrasco, C., Del Carmen, M., García, Y., Alba, A., Gurdiel, E., Dorronzoro, E., Muniesa, M.J., Lu, D.-W., Clearkin, L.G., Patwala, Y. (2007-03). 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. ScholarBank@NUS Repository.
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. © Wichtig Editore, 2007.
Source Title: European Journal of Ophthalmology
URI: http://scholarbank.nus.edu.sg/handle/10635/129793
ISSN: 11206721
Appears in Collections:Staff Publications

Show full item record
Files in This Item:
There are no files associated with this item.

Page view(s)

51
checked on May 22, 2019

Google ScholarTM

Check


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.