Three-month evaluation of dorzolamide hydrochloride/timolol maleate fixed-combination eye drops versus the separate use of both drugs

Inoue, Kenji; Shiokawa, Minako; Sugahara, Michitaka; Wakakura, Masato; Soeda, Shoichi; Tomita, Goji

doi:10.1007/s10384-012-0186-8

Cited by 20 publications

(17 citation statements)

References 17 publications

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“…The LTFC eye drops had varying effects on IOP [2–7], but IOP did not change after switching to DTFC eye drops [8–11]. Our results are in agreement with these observations.…”

Section: Discussionsupporting

confidence: 89%

Comparison of Latanoprost/Timolol with Carbonic Anhydrase Inhibitor and Dorzolamide/Timolol with Prostaglandin Analog in the Treatment of Glaucoma

Inoue

Soeda

Tomita

2014

Journal of Ophthalmology

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Purpose. We retrospectively reviewed medical records of glaucoma patients to investigate how switching medications may affect intraocular pressure (IOP) management. Three concomitant medications were changed to two medications: one combination drop and one single-action drop. Associated adverse effects were also examined. Subjects and Methods. A total of 112 patients with primary open-angle glaucoma or ocular hypertension were examined. All patients were concomitantly using a prostaglandin (PG) analog, a β-blocker, and a carbonic anhydrate inhibitor (CAI). Fifty-five patients began using latanoprost (PG analog)/timolol (β-blocker) fixed-combination (LTFC) drops and a CAI (group 1), and 57 patients began using dorzolamide (CAI)/timolol fixed-combination (DTFC) drops and a PG analog (group 2). The IOP was measured every 6 months for 2 years following medication changes. Changes in visual field mean deviation (MD) and medication discontinuations were also examined. Results. There were no significant differences in IOP or MD values before and after medication changes in either group. The proportion of medication discontinuations, uncontrolled IOP, and adverse reactions was similar in both groups. Conclusion. Switching patients from multiple single-action medications to combination medications was not associated with changes in IOP, visual field testing results, or adverse event frequency.

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“…The LTFC eye drops had varying effects on IOP [2–7], but IOP did not change after switching to DTFC eye drops [8–11]. Our results are in agreement with these observations.…”

Section: Discussionsupporting

confidence: 89%

Comparison of Latanoprost/Timolol with Carbonic Anhydrase Inhibitor and Dorzolamide/Timolol with Prostaglandin Analog in the Treatment of Glaucoma

Inoue

Soeda

Tomita

2014

Journal of Ophthalmology

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“…Similar to the current study, which demonstrated comparable efficacy of BRINZ/TIM-FC and unfixed concomitant BRINZ + TIM, other clinical assessments of fixed-combination therapies have demonstrated that fixed-combination pharmacotherapies containing TIM and dorzolamide, a carbonic anhydrase inhibitor, or latanoprost, a prostaglandin analog, have efficacy similar to that of concomitant treatment with their active components 32–35. Fixed-combination dorzolamide 1%/TIM is approved for use in Japan; there are currently no comparative data for BRINZ/TIM-FC versus the fixed combination of dorzolamide 1%/TIM.…”

Section: Discussionsupporting

confidence: 80%

Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension

Nagayama¹,

Nakajima²,

Ono³

2014

OPTH

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BackgroundThe purpose of this study was to assess the safety and efficacy of fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC) compared with concomitant brinzolamide 1% and timolol 0.5% (BRINZ + TIM) in Japanese patients with open-angle glaucoma (primary open-angle, exfoliation, pigmentary) or ocular hypertension.MethodsThis randomized, double-masked, multicenter, parallel-group, positive-control, Phase III study was conducted in Japan and included patients aged ≥20 years. Baseline intraocular pressure was assessed after 4 weeks of treatment with timolol 0.5%. Patients were randomized to twice-daily BRINZ/TIM-FC or BRINZ + TIM for 8 weeks (treatment phase). The primary endpoint was mean intraocular pressure reduction from baseline to week 8 at 11 am, at which time noninferiority of BRINZ/TIM-FC versus BRINZ + TIM was evaluated. Data were analyzed using repeated-measures analysis of covariance and t-tests. Adverse events and ophthalmic/physiologic variables were assessed.ResultsIn total, 319 patients of mean age 64±12 years were enrolled in the treatment phase. BRINZ/TIM-FC and BRINZ + TIM were associated with reductions in mean intraocular pressure from baseline throughout the study (ranges −2.5 to −3.4 mmHg and −2.7 to −3.3 mmHg, respectively). Mean between-group differences in intraocular pressure reduction ranged from 0 to −0.3 mmHg; the upper limit of the 97.5% confidence interval for week 8 at 11 am was <1.1 mmHg, indicating noninferiority of BRINZ/TIM-FC. Treatment-related adverse events were observed in 3% and 12% of patients receiving BRINZ/TIM-FC and BRINZ + TIM, respectively. No substantial changes in other safety parameters were reported.ConclusionTwice-daily BRINZ/TIM-FC reduced intraocular pressure by levels similar to concomitant BRINZ + TIM in Japanese patients with open-angle glaucoma or ocular hypertension and was noninferior to BRINZ + TIM. Both treatments were well tolerated.

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“…Patients were eligible if they were receiving treatment with multiple IOP-lowering drugs (including combination drugs) at screening, or if they were treated with a single IOP-lowering drug and had insufficient IOP reduction at screening. Insufficient IOP reduction was defined as IOP >18 mmHg in at least one eye at the screening visit (primary open-angle, exfoliation, or pigmentary glaucoma)28,29 or IOP elevation <30% from the screening visit to the baseline visit (normal-tension glaucoma). In previous studies, reducing IOP to <18 mmHg in patients with open-angle glaucoma or by ≥30% in patients with normal-tension glaucoma resulted in slower rates of visual field progression 9,30,31.…”

Section: Methodsmentioning

confidence: 99%

Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension

Nakajima¹,

Iwasaki²,

Adachi³

2013

OPTH

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BackgroundThe purpose of this study was to evaluate the safety and efficacy of a long-term, twice-daily brinzolamide 1%/timolol 0.5% fixed combination ophthalmic suspension (BRINZ/TIM-FC) in Japanese patients with open-angle glaucoma (primary open-angle, normal-tension, exfoliation, or pigmentary) or ocular hypertension.MethodsThis was a prospective, nonrandomized, multicenter, open-label, Phase III study of Japanese patients aged ≥20 years with diagnoses of open-angle glaucoma or ocular hypertension. Patients were treated with topical BRINZ/TIM-FC twice daily for 52 weeks. The primary endpoint was mean reduction from baseline in intraocular pressure. Data were analyzed using repeated-measures analysis of variance and t-tests. Adverse events and ophthalmic, physiologic, and laboratory parameters were measured throughout the study as safety endpoints. A total of 126 patients (mean ± SD age, 63±12 years) were enrolled, and 125 received BRINZ/TIM-FC.ResultsMean intraocular pressure was significantly reduced from baseline at weeks 4 through 52, with changes ranging from −4.1 mmHg to −5.7 mmHg (P<0.0001, all time points). Adverse events related to BRINZ/TIM-FC treatment were observed in 22% of patients. No substantial changes from baseline were observed in ophthalmic, physiologic, or laboratory variables.ConclusionLong-term, twice-daily BRINZ/TIM-FC therapy produced and maintained significant intraocular pressure reductions and was generally well tolerated in Japanese patients with open-angle glaucoma or ocular hypertension.

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Three-month evaluation of dorzolamide hydrochloride/timolol maleate fixed-combination eye drops versus the separate use of both drugs

Abstract: The replacement of concomitant treatment with dorzolamide hydrochloride 1 % and timolol maleate 0.5 % eye drops with dorzolamide hydrochloride 1 %/timolol maleate 0.5 % fixed-combination eye drops improved protocol adherence and preserved the IOP.

Cited by 20 publications

References 17 publications

Comparison of Latanoprost/Timolol with Carbonic Anhydrase Inhibitor and Dorzolamide/Timolol with Prostaglandin Analog in the Treatment of Glaucoma

Comparison of Latanoprost/Timolol with Carbonic Anhydrase Inhibitor and Dorzolamide/Timolol with Prostaglandin Analog in the Treatment of Glaucoma

Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension

Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension

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