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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

Publicated to:European Journal Of Ophthalmology. 17 (2): 183-190 - 2007-01-01 17(2), DOI: 10.1177/112067210701700206

Authors: Topouzis F; Melamed S; Danesh-Meyer H; Wells AP; Kozobolis VP; Wieland H; Andrew R; Wells D; 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; 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 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 D-W; Clearkin LG; Patwala Y

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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.

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