A randomized, investigator-masked, 4-week study comparing timolol maleate 0.5%, brinzolamide 1%, and brimonidine tartrate 0.2% as adjunctive therapies to travoprost 0.004% in adults with primary open-angle glaucoma or ocular hypertension

Reis, Ricardo Prado Abreu; Queiroz, Carlos F.; Santos, Lúcia C.; Ávila, Marcos Pereira de; Magacho, Leopoldo

doi:10.1016/j.clinthera.2006.04.007

Cited by 49 publications

(45 citation statements)

References 20 publications

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“…Our results differ from those of Reis et al and Hollo et al Reis and colleagues [19] found in an open-label study that addition of brinzolamide to travoprost had, after 28 days of treatment, the same IOP reduction effect as timolol maleate 0.5% twice daily added to travoprost. The results of their study showed no statistically significant differences for IOP reduction or percent reduction between the two groups.…”

Section: Discussioncontrasting

confidence: 84%

Timolol versus brinzolamide added to travoprost in glaucoma or ocular hypertension

Pfeiffer¹

2011

Graefes Arch Clin Exp Ophthalmol

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Section: Discussioncontrasting

confidence: 84%

Timolol versus brinzolamide added to travoprost in glaucoma or ocular hypertension

Pfeiffer¹

2011

Graefes Arch Clin Exp Ophthalmol

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“…In this regard, an additional IOP reduction of 10 to 28% at peak (at the moment of maximal IOP-lowering drug effect) has been observed in glaucoma patients when brimonidine (administered 2 to 3 times daily) (Simmons, 2001;Solish et al, 2004;Akman et al, 2005), dorzolamide (administered 2 to 3 times daily) (Hutzelmann et al, 1998;Hartenbaum et al, 1999;Kaluzny et al, 2003), or latanoprost (administered once daily) (Orengo-Nania et al, 2001;Akman et al, 2005) were added to a timolol regimen for long-term use (Webers et al, 2008). Moreover, an extra IOP decrease of 19 to 20% at peak has been obtained when timolol were added to a latanoprost or travoprost regimen (both administered once daily) for longterm use (Stewart et al, 1999;Reis et al, 2006).…”

Section: Discussionmentioning

confidence: 99%

Melatonin and Its Analog 5-Methoxycarbonylamino-N-Acetyltryptamine Potentiate Adrenergic Receptor-Mediated Ocular Hypotensive Effects in Rabbits: Significance for Combination Therapy in Glaucoma

Crooke

Huete-Toral

Martínez-Águila

et al. 2013

J Pharmacol Exp Ther

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Melatonin is currently considered a promising drug for glaucoma treatment because of its ocular hypotensive and neuroprotective effects. We have investigated the effect of melatonin and its analog 5-methoxycarbonylamino-N-acetyltryptamine, 5-MCA-NAT, on b 2 /a 2A -adrenergic receptor mRNA as well as protein expression in cultured rabbit nonpigmented ciliary epithelial cells. Quantitative polymerase chain reaction and immunocytochemical assays revealed a significant b 2 -adrenergic receptor downregulation as well as a 2A -adrenergic receptor up-regulation of treated cells (P , 0.001, maximal significant effect). In addition, we have studied the effect of these drugs upon the ocular hypotensive action of a nonselective b-adrenergic receptor (timolol) and a selective a 2 -adrenergic receptor agonist (brimonidine) in normotensive rabbits. Intraocular pressure (IOP) experiments showed that the administration of timolol in rabbits pretreated with melatonin or 5-MCA-NAT evoked an additional IOP reduction of 14.02% 6 5.8% or 16.75% 6 5.48% (P , 0.01) in comparison with rabbits treated with timolol alone for 24 hours. Concerning brimonidine hypotensive action, an additional IOP reduction of 29.26% 6 5.21% or 39.07% 6 5.81% (P , 0.001) was observed in rabbits pretreated with melatonin or 5-MCA-NAT when compared with animals treated with brimonidine alone for 24 hours. Additionally, a sustained potentiating effect of a single dose of 5-MCA-NAT was seen in rabbits treated with brimonidine once daily for up 4 days (extra IOP decrease of 15.57% 6 5.15%, P , 0.05, compared with brimonidine alone). These data confirm the indirect action of melatoninergic compounds on adrenergic receptors and their remarkable effect upon the ocular hypotensive action mainly of a 2 -adrenergic receptor agonists but also of b-adrenergic antagonists.

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“…Both brinzolamide and brimonidine have been used as a part of other fixed-combination therapies (with timolol), and both have shown clinically relevant IOP reductions when used adjunctively with a PGA. [10][11][12] BBFC, which contains only 0.003% benzalkonium chloride, represents a fixed-combination option for patients with contraindications to beta antagonists. The current study used a randomized design to measure the contribution of the individual active ingredients of BBFC and to assess its safety.…”

Section: Introductionmentioning

confidence: 99%

Phase 3 Randomized 3-Month Trial with an Ongoing 3-Month Safety Extension of Fixed-Combination Brinzolamide 1%/Brimonidine 0.2%

Nguyen

McMenemy

Realini

et al. 2013

Journal of Ocular Pharmacology and Therapeutics

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Purpose: This study compared the intraocular pressure (IOP)-lowering efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) with that of its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension. Patients and Methods: In this phase 3, multicenter, double-masked, parallel-group, 3-month study with a 3-month safety extension, eligible patients were randomized 1:1:1 to treatment with BBFC, brinzolamide, or brimonidine thrice daily after a washout period, during which any IOP-lowering medications were discontinued. The primary objectives of this study were to determine whether the IOP-lowering efficacy of BBFC was superior to that of brinzolamide alone and, separately, of brimonidine alone. IOP was assessed at 8:00 AM, 10:00 AM, 3:00 PM, and 5:00 PM at 2 weeks, 6 weeks, and 3 months after study drug initiation. Results: A total of 690 patients were enrolled in the study, and 615 completed the 3-month visit. Baseline mean IOP levels were similar among the 3 treatment groups at each of the 4 time points assessed. At the 3-month primary endpoint, mean IOP of the BBFC group was significantly lower than that of either the brinzolamide group or the brimonidine group (P £ 0.005) across all time points. At the 2-and 6-week supportive endpoints, mean IOP of the BBFC group was significantly lower at all time points than the mean IOP of either the brinzolamide group (P £ 0.01) or the brimonidine group (P < 0.0001). A total of 143 patients experienced at least 1 treatment-related adverse event (AE; BBFC group, n = 58, 26.2%; brinzolamide group, n = 44, 18.8%; brimonidine group, n = 41, 17.4%), the majority of which were ocular AEs. Conclusions: This study demonstrated that BBFC has significantly superior IOP-lowering activity compared with either brinzolamide 1% or brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension while providing a safety profile which is consistent with that of the individual components.

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A randomized, investigator-masked, 4-week study comparing timolol maleate 0.5%, brinzolamide 1%, and brimonidine tartrate 0.2% as adjunctive therapies to travoprost 0.004% in adults with primary open-angle glaucoma or ocular hypertension

Cited by 49 publications

References 20 publications

Timolol versus brinzolamide added to travoprost in glaucoma or ocular hypertension

Timolol versus brinzolamide added to travoprost in glaucoma or ocular hypertension

Melatonin and Its Analog 5-Methoxycarbonylamino-N-Acetyltryptamine Potentiate Adrenergic Receptor-Mediated Ocular Hypotensive Effects in Rabbits: Significance for Combination Therapy in Glaucoma

Phase 3 Randomized 3-Month Trial with an Ongoing 3-Month Safety Extension of Fixed-Combination Brinzolamide 1%/Brimonidine 0.2%

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