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Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice

View Article: PubMed Central - PubMed

ABSTRACT

Purpose: The aim of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF), fixed-combination (FC) bimatoprost 0.03%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension in a clinical practice setting.

Patients and methods: This open-label study observed patients switched to PF FC bimatoprost 0.03%/timolol 0.5% due to insufficient intraocular pressure (IOP) control on previous therapies. IOP was measured at baseline and at ~12 weeks. Tolerability and continuation of therapy were also assessed.

Results: A total of 1,553 patients were included in the study, and the per-protocol population comprised 1,391 patients. There were some minor deviations from protocol: some patients with no prior therapy and some who switched for reasons other than insufficient IOP control were included in the analysis. The mean IOP was reduced by 27.4%, from 22.2 mmHg to 16.1 mmHg. In subgroup analyses, the mean IOP was significantly reduced from baseline, irrespective of whether previous treatment was monotherapy or combination therapy, and preserved or PF therapy. Physicians mostly (88.1%) reported the IOP-lowering efficacy of PF FC bimatoprost 0.03%/timolol 0.5% to be as expected or better than expected. Switching to PF FC bimatoprost 0.03%/timolol 0.5% resulted in reductions from baseline in the number of patients reporting ocular symptoms. Adverse events were reported by 6.2% of patients, the most common being eye irritation (1.6%) and eye pruritus (1.0%). Physicians reported treatment compliance as better or unchanged compared with prior treatment in almost all patients (93.9%). Most patients were expected to continue PF FC bimatoprost 0.03%/timolol 0.5% after the end of the study.

Conclusion: Switching to PF FC bimatoprost 0.03%/timolol 0.5% was associated with significant IOP reductions from baseline over 12 weeks. Adverse events were uncommon, and compliance was high compared with previous therapy. PF FC bimatoprost 0.03%/timolol 0.5% may be a suitable treatment for patients with inadequately controlled IOP or who are sensitive to preservatives.

No MeSH data available.


Related in: MedlinePlus

IOP in patients who switched from prior IOP-lowering monotherapy or combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population).Notes: (A) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering monotherapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). (B) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering fixed-dose combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). Data reported for the study eye in patients with complete data at all visits. *P<0.0001 (paired t-test). #Preservative status not disclosed/PF formulation not available.Abbreviations: Bim, bimatoprost; Bzd, brinzolomide; Dzd, dorzolamide; FC, fixed combination; IOP, intraocular pressure; Lat, latanoprost; P, preserved; PF, preservative free; PGA, prostaglandin; Taf, tafluprost; Trav, travatan.
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f4-opth-10-1837: IOP in patients who switched from prior IOP-lowering monotherapy or combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population).Notes: (A) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering monotherapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). (B) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering fixed-dose combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). Data reported for the study eye in patients with complete data at all visits. *P<0.0001 (paired t-test). #Preservative status not disclosed/PF formulation not available.Abbreviations: Bim, bimatoprost; Bzd, brinzolomide; Dzd, dorzolamide; FC, fixed combination; IOP, intraocular pressure; Lat, latanoprost; P, preserved; PF, preservative free; PGA, prostaglandin; Taf, tafluprost; Trav, travatan.

Mentions: There was no significant between-group difference for patients switching to PF FC bimatoprost 0.03%/timolol 0.5% from either a preserved or a nonpreserved prior therapy. For patients on a prior preserved IOP-lowering therapy, mean ± SD IOP was 22.1±3.2 mmHg at baseline and 16.1±2.8 mmHg at the final visit, a reduction of 6.0 mmHg (−27.3%; P<0.0001, n=918). For patients on a prior PF IOP-lowering therapy, mean ± SD IOP was 21.8±3.1 mmHg at baseline and 16.2±2.5 mmHg at the final visit, a reduction of 5.6 mmHg (−25.8%; P<0.0001, n=202). For all other prior IOP-lowering therapy subgroups analyzed, PF FC bimatoprost 0.03%/timolol 0.5% significantly decreased mean IOP compared with baseline (Figure 4), including in patients switching from PF bimatoprost (a reduction of 5.6 mmHg; P<0.0001, n=20). At the final study visit, the majority of physicians reported that the IOP-lowering efficacy of PF FC bimatoprost 0.03%/timolol 0.5% was better than or as expected (88.1%).


Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice
IOP in patients who switched from prior IOP-lowering monotherapy or combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population).Notes: (A) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering monotherapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). (B) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering fixed-dose combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). Data reported for the study eye in patients with complete data at all visits. *P<0.0001 (paired t-test). #Preservative status not disclosed/PF formulation not available.Abbreviations: Bim, bimatoprost; Bzd, brinzolomide; Dzd, dorzolamide; FC, fixed combination; IOP, intraocular pressure; Lat, latanoprost; P, preserved; PF, preservative free; PGA, prostaglandin; Taf, tafluprost; Trav, travatan.
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Related In: Results  -  Collection

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f4-opth-10-1837: IOP in patients who switched from prior IOP-lowering monotherapy or combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population).Notes: (A) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering monotherapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). (B) IOP in patients who switched from preserved and nonpreserved prior IOP-lowering fixed-dose combination therapy to PF FC bimatoprost 0.03%/timolol 0.5% (per-protocol population). Data reported for the study eye in patients with complete data at all visits. *P<0.0001 (paired t-test). #Preservative status not disclosed/PF formulation not available.Abbreviations: Bim, bimatoprost; Bzd, brinzolomide; Dzd, dorzolamide; FC, fixed combination; IOP, intraocular pressure; Lat, latanoprost; P, preserved; PF, preservative free; PGA, prostaglandin; Taf, tafluprost; Trav, travatan.
Mentions: There was no significant between-group difference for patients switching to PF FC bimatoprost 0.03%/timolol 0.5% from either a preserved or a nonpreserved prior therapy. For patients on a prior preserved IOP-lowering therapy, mean ± SD IOP was 22.1±3.2 mmHg at baseline and 16.1±2.8 mmHg at the final visit, a reduction of 6.0 mmHg (−27.3%; P<0.0001, n=918). For patients on a prior PF IOP-lowering therapy, mean ± SD IOP was 21.8±3.1 mmHg at baseline and 16.2±2.5 mmHg at the final visit, a reduction of 5.6 mmHg (−25.8%; P<0.0001, n=202). For all other prior IOP-lowering therapy subgroups analyzed, PF FC bimatoprost 0.03%/timolol 0.5% significantly decreased mean IOP compared with baseline (Figure 4), including in patients switching from PF bimatoprost (a reduction of 5.6 mmHg; P<0.0001, n=20). At the final study visit, the majority of physicians reported that the IOP-lowering efficacy of PF FC bimatoprost 0.03%/timolol 0.5% was better than or as expected (88.1%).

View Article: PubMed Central - PubMed

ABSTRACT

Purpose: The aim of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF), fixed-combination (FC) bimatoprost 0.03%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension in a clinical practice setting.

Patients and methods: This open-label study observed patients switched to PF FC bimatoprost 0.03%/timolol 0.5% due to insufficient intraocular pressure (IOP) control on previous therapies. IOP was measured at baseline and at ~12 weeks. Tolerability and continuation of therapy were also assessed.

Results: A total of 1,553 patients were included in the study, and the per-protocol population comprised 1,391 patients. There were some minor deviations from protocol: some patients with no prior therapy and some who switched for reasons other than insufficient IOP control were included in the analysis. The mean IOP was reduced by 27.4%, from 22.2 mmHg to 16.1 mmHg. In subgroup analyses, the mean IOP was significantly reduced from baseline, irrespective of whether previous treatment was monotherapy or combination therapy, and preserved or PF therapy. Physicians mostly (88.1%) reported the IOP-lowering efficacy of PF FC bimatoprost 0.03%/timolol 0.5% to be as expected or better than expected. Switching to PF FC bimatoprost 0.03%/timolol 0.5% resulted in reductions from baseline in the number of patients reporting ocular symptoms. Adverse events were reported by 6.2% of patients, the most common being eye irritation (1.6%) and eye pruritus (1.0%). Physicians reported treatment compliance as better or unchanged compared with prior treatment in almost all patients (93.9%). Most patients were expected to continue PF FC bimatoprost 0.03%/timolol 0.5% after the end of the study.

Conclusion: Switching to PF FC bimatoprost 0.03%/timolol 0.5% was associated with significant IOP reductions from baseline over 12 weeks. Adverse events were uncommon, and compliance was high compared with previous therapy. PF FC bimatoprost 0.03%/timolol 0.5% may be a suitable treatment for patients with inadequately controlled IOP or who are sensitive to preservatives.

No MeSH data available.


Related in: MedlinePlus