An Eight-week, Multicentric, Randomized, Interventional, Open-label, Phase 4, Parallel Comparison of the Efficacy and Tolerability of the Fixed Combination of Timolol Maleate 0.5%/Brimonidine Tartrate 0.2% Versus Fixed Combination of Timolol Maleate 0.5%/Dorzolamide 2% in Patients With Elevated Intraocular Pressure

Abstract

Both fixed combinations were capable of significantly reducing the mean diurnal IOP, mean diurnal peak, and mean WDT peak after 8 weeks of treatment. Also, both fixed combinations are well tolerated with few side effects.

Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma

“…Although most previously published daytime studies 28,29 have demonstrated similar IOP-lowering efficacy for BTFC over DTFC, a recent 3-month parallel-arm study by Nixon et al 38 reported a greater IOP reduction with BTFC monotherapy (À7.7 mm Hg) compared with DTFC monotherapy (À6.7 mm Hg). The study by Nixon et al 38 pooled data from two separate trials: a single site pilot study with 40 patients, and a multi-centre trial with 140 patients.…”

“…Our results demonstrated a significant difference between DTFC and BTFC (À0.7 mm Hg over a 24-h period), unlike the findings of the two previous daytime studies in which no significant difference was detected. 28,29 Significant differences in this study design compared with those previous studies include: (1) crossover design vs parallel arm, (2) inclusion of only POAG patients, (3) a higher baseline untreated IOP, (4) exclusion of patients adequately responding to timolol monotherapy, and (5) a more complete 24-h IOP evaluation of the two fixed combinations. All of the above factors contributed to a greater power in this study to detect small but significant differences between the two fixed combinations.…”

“…At present, there are few data from randomised clinical studies directly comparing these two fixed combinations, and the data that have been reported suggest similar daytime efficacy. 28,29 A more detailed comparison of the efficacy of the two combinations can be made by recording IOP throughout a 24-h period. 30 The purpose of the present study is to compare the difference in IOP-lowering efficacy when measured over 24 h, between these two fixed combinations in patients with primary open-angle glaucoma (POAG).…”

Reprodutibilidade do testes de sobrecarga hídrica

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Nos últimos anos nosso grupo avaliou o TSH em diversas situações relacionadas ao controle pressórico em pacientes com diagnóstico já estabelecido e submetidos ou não a terapia clínica e (ou) cirúrgica, com diferentes níveis de dano glaucomatoso e com evoluções diferentes em relação à progressão da doença (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11) . A utilização do TSH para avaliar controle pressórico em olhos sob terapia clínica também passou a ser estudada por centros de pesquisa em outras partes do mundo como Estados Unidos e Europa (12)(13)(14)(15)(16)(17)(18) .

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“…Em resumo, o número expressivo de trabalhos e editoriais publicados recentemente em vários centros internacionais e com centenas de pacientes estudados sugerem a potencialidade deste teste em fornecer informações complementares importantes na avaliação do controle pressórico de pacientes glaucomatosos (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(21)(22) . …”