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.
|Titolo:||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|
|Data di pubblicazione:||2007|
|Citazione:||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 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.ae; Goldenfeld; M.ae; Verbin; H.ae; Vilner; Z.ae; Knaan; R.ae; Moroz; I.ae; Geyer; O.af; Segev; E.af; Kurtz; S.ag; Neudorfer; M.ag; Shemesh; G.ag; Zayit; S.ag; Volksone; L.ah; Karlsone; L.ah; Laganovska; G.ai; Baumane; K.ai; Egite; I.ai; Januleviciene; I.aj; Kuzmiene; L.aj; Danesh-Meyer; H.ak; Wells; A.P.al; Riley; A.al; Bedggood; A.al; Long; H.al; Ashraff; N.al; Abrantes; P.A.L.am; Reina; M.am; Silva; J.P.am; Ilharco; J.am; Chew; P.T.K.an; Thean; L.an; Lim; B.A.an ao; Manuel; J.an; Loon; S.C.an; Tan; C.an; Yeong; S.M.an; Seah; S.K.L.ao; Oen; F.ao; Husain; R.ao; Hoh; S.T.ao; Tin; A.ao; Sánchez; J.G.ap; Feijoo; J.G.ap; De La Casa; J.M.M.ap; Gómez; A.C.ap; López; F.M.H.aq; Llorens; V.P.aq; Júlvez; L.P.aq; Martínez; M.L.G.aq; Póvez; J.M.L.aq; Arias-Puente; A.ar; Carrasco; C.ar; Del Carmen; M.ar; García; Y.ar; Alba; A.ar; Gurdiel; E.as; Dorronzoro; E.as; Muniesa; M.J.as; Lu; D.-W.at; Clearkin; L.G.au; Patwala; Y.. - In: EUROPEAN JOURNAL OPHTALMOLOGY. - ISSN 1724-6016. - 17:2(2007), pp. 183-190.|
|Appare nelle tipologie:||1.1 Articolo in rivista|