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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.
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
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
ISSN: 11206721
Appears in Collections:Staff Publications

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