The Safety and Efficacy of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 2%/Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension

PurposeTo compare the additive effects and safety of 1% brinzolamide/0.5% timolol fixed combination (BTFC) versus the low‐dose regimen of 1% dorzolamide/0.5% timolol fixed combination (DTFC) in patients with open‐angle glaucoma and ocular hypertension (OAG/OH) following treatment with prostaglandin analogues (PGAs).MethodsA prospective, randomized, double‐masked, multicentre, parallel‐group and active‐controlled study included 201 Japanese OAG/OH patients who had been treated with PGA. Efficacy was assessed as the change in intra‐ocular pressure (IOP) from baseline after weeks 4 and 8. Safety was assessed with adverse event rates, ocular discomfort score, blur scale, blood pressure and heart rates, best‐corrected visual acuity (BCVA) and slit lamp examinations.ResultsIntra‐ocular pressure (IOP) change from baseline at 9 AM/11 AM pooled over the 8 weeks was −3.3/−3.3 mmHg in the BTFC group and −2.9/−3.4 mmHg in the DTFC group, demonstrating non‐inferiority of BTFC to DTFC. Ocular irritation was frequently seen in DTFC group. Although blurred vision was frequently seen in BTFC group, it was transient and blurring became the equivalent 3 min after instillation between two groups. No noteworthy issue was observed in other safety outcome.ConclusionNon‐inferiority of BTFC to DTFC in IOP reduction was demonstrated after adding onto PGA therapy in Japanese OAG/OH patients. Although the score of blurred vision was transiently higher in BTFC than DTFC, treatment difference decreased and disappeared with time. Thus, BTFC can be considered as a safe and effective agent for glaucoma treatment.

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“…2009). In a study by Manni et al., BTFC or 2% DTFC was applied alone to the eyes of patients with OH or OAG.…”

Section: Discussionmentioning

confidence: 99%

“…This non‐inferiority margin (1.5 mmHg) was selected from a previous study with a similar design (Manni et al. 2009). …”

Section: Methodsmentioning

confidence: 99%

Additive effects and safety of fixed combination therapy with 1% brinzolamide and 0.5% timolol versus 1% dorzolamide and 0.5% timolol in prostaglandin‐treated glaucoma patients

Aihara

Adachi

Matsuo

et al. 2017

Acta Ophthalmologica

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“…Desses pacientes, dois queixaram de ardência (7,7%), um de embaçamento (3,8%) e um de leve queimação (3,8%). Na literatura encontramos estudos que comparam uma medicação com outra, onde em todas as comparações apresentaram resultados favorá-veis à combinação de timolol com brinzolamida (5,10,11) . A combinação de timolol 0,5% com brinzolamida 1% mostrou-se eficaz no controle da PIO com índices de redução semelhantes à literatura e mostrou um baixo índice de desconforto nos pacientes acompanhados.…”

Section: Discussionunclassified

Eficácia da combinação fixa de timolol 0,5% e brinzolamida 1% no tratamento do glaucoma primário de ângulo aberto e na hipertensão ocular

Almodin¹,

Junior²,

Almodin³

et al. 2012

Rev. bras.oftalmol.

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Eficácia da combinação fixa de timolol 0,5% e brinzolamida 1% no tratamento do glaucoma primário de ângulo aberto e na hipertensão ocular RESUMOObjetivo: Avaliar a eficácia e conforto dos pacientes portadores de glaucoma primário de ângulo aberto (GPAA) ou hipertensão ocular (HO) em uso da combinação fixa de timolol 0,5% e brinzolamida 1%. Métodos: Foram acompanhados prospectivamente 26 pacientes portadores de GPAA ou HO, num total de 50 olhos que foram instituídos a utilizarem a combinação fixa de timolol 0,5% e brinzolamida 1%. As avaliações foram feitas por um único examinador por tonometria de aplanação (Goldman) em 7 e 30 dias. Os possíveis efeitos colaterais e intolerância foram descritos pelos próprios pacientes através da pergunta: "Você sentiu alguma alteração ao pingar a medicação prescrita?" Os dados foram coletados e analisados estatisticamente. Resultados: Os valores de pressão intraocular (PIO) foram significativamente menores nas avaliações de 7 e 30 dias (p<0,001). A média da redução da PIO foi de 38%, variando de uma média inicial de 23,8 mmHg para 14,6 e 14,4 mmHg nos dias 7 e 30, respectivamente. Dos 26 pacientes incluídos apenas 4 relataram alguma queixa ao pingar o colírio, sendo que as queixas variaram de ardência, leve queimação e embaçamento. Conclusão: A combinação fixa de timolol 0,5% e brinzolamida 1% mostrou-se eficaz no tratamento de pacientes com GPAA e HO com eficácia semelhante a da literatura e apresentou um baixo índice de efeitos desconfortáveis relatados pelos usuários da medicação.

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“…The impact of physiological pH on compliance has recently been accentuated by the makers of Azarga. 25,24 However, this claim was only compared with Cosopt, and not set in the context of a survey of the pH of all other glaucoma products. The lack of easily available information regarding the pH of commonly used glaucoma medications was the main motivation for this study.…”

Section: Clinical Relevancementioning

confidence: 99%

“…A patient preference study found greater comfort associated with the physiological pH of the brinzolamide-based suspensions compared with the more acidic dorzolamide-based solutions and concluded that differences in ocular discomfort and adverse effects were likely to be attributable to the pH and formulation differences given the similarities of the active ingredients in the two combination products investigated. 24,23 In other words, excipients could have a role in patient tolerance and subsequent therapeutic compliance, independent of preservatives.…”

Section: Chemical Composition (Ph)mentioning

confidence: 99%

Free radicals and the pH of topical glaucoma medications: a lifetime of ocular chemical injury?

Lockington

Macdonald

Stewart

et al. 2012

Eye

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Introduction Preservatives in ophthalmic preparations are known to cause ocular surface damage. Excipients can also contribute to oxidative stress in the compromised ocular surface. We evaluated commonly used topical glaucoma medications to ascertain pH levels and the intrinsic presence of free radicals. Methods Samples of 27 topical glaucoma preparations were analysed for total free radical presence using a Randox Kit for total antioxidant status. Analytical grade indicator paper was used to ascertain pH levels. Results Free radical concentrations for these 27 glaucoma preparations ranged from 0 to 4.54 mmol/l, with a median value of 0.66 mmol/l (mean value of 0.662 mmol/l, SD 0.839). Levels of pH ranged from 4.0 to 7.4, with a median value of 6.5 (mean 6.252, SD 0.826). There was no evidence of a direct correlation between these two variables (r ¼ 0.232, P ¼ 0.275). Conclusion This study is the first to document the range of pH and concentrations of free radicals intrinsically present in commonly used glaucoma medications. Long-term exposure to preservatives, free radicals, and pH levels could all contribute to ocular surface damage. The effect of excipients could be responsible for patient intolerance when changing products in the compromised ocular surface.

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The Safety and Efficacy of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 2%/Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension

Abstract: Brinz/Tim suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is noninferior to Dorz/Tim. Additionally, Brinz/Tim affords an ocular comfort advantage compared with Dorz/Tim.

Cited by 70 publications

References 27 publications

Additive effects and safety of fixed combination therapy with 1% brinzolamide and 0.5% timolol versus 1% dorzolamide and 0.5% timolol in prostaglandin‐treated glaucoma patients

Additive effects and safety of fixed combination therapy with 1% brinzolamide and 0.5% timolol versus 1% dorzolamide and 0.5% timolol in prostaglandin‐treated glaucoma patients

Eficácia da combinação fixa de timolol 0,5% e brinzolamida 1% no tratamento do glaucoma primário de ângulo aberto e na hipertensão ocular

Free radicals and the pH of topical glaucoma medications: a lifetime of ocular chemical injury?

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