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Switching patients from preserved prostaglandin-analog monotherapy to preservative-free tafluprost.

Hommer A, Kimmich F - Clin Ophthalmol (2011)

Bottom Line: All adverse events were recorded.Preservative-free tafluprost 0.0015% was effective, well tolerated and safe.IOP was controlled effectively and ocular symptoms and clinical signs were improved after changing medication to a monotherapy with preservative-free tafluprost in patients previously treated with a preserved latanoprost, travoprost or bimatoprost monotherapy.

View Article: PubMed Central - PubMed

Affiliation: Sanatorium Hera, Vienna, Austria.

ABSTRACT

Purpose: Efficacy, tolerability and safety of the novel preservative-free prostaglandin tafluprost 0.0015% were investigated for the treatment of patients with glaucoma or ocular hypertension in a clinical setting.

Patients and methods: Data were collected in a non-interventional, prospective, multi-center, observational, open label study. 118 patients were treated with a prostaglandin analog (PGA) monotherapy (preserved formulations of latanoprost, travoprost or bimatoprost) prior to baseline. Intraocular pressure (IOP) readings were recorded for each eye at baseline (previous therapy), 4-6 weeks, and 12 weeks after changing medical treatment to preservative-free tafluprost once-daily. We analyzed the change in IOP over the study period for all patients as well as for a subgroup of patients with prior PGA monotherapy. Subjective symptoms and objective ocular signs were determined. Comfort was measured using a 4 step scale. All adverse events were recorded. Paired t-tests were conducted to compare IOP values at baseline to IOP values after treatment with tafluprost 0.0015%. Bowker's test of symmetry was used for statistical evaluation of changes of clinical signs (hyperemia).

Results: In total 118 patients were eligible for evaluation. In these patients with prior PGA monotherapy (n = 118) IOP decreased significantly from 16.2 ± 4.3 mm Hg (95% CI: 0.55) at treated baseline to 14.8 ± 3.2 mm Hg (95% CI: 0.43; P < 0.001) at final visit on tafluprost. In a subset of patients with prior latanoprost monotherapy (n = 68) mean IOP at baseline (±SD) was reduced from 16.2 ± 4.6 mm Hg (95% CI: 0.77) 14.8 ± 3.1 mm Hg at final visit (95% CI: 0.54, P < 0.001), in patients with prior travoprost monotherapy (n = 32) from 16.2 ± 4.3 mm Hg (95% CI: 1.05) to 14.9 ± 3.3 mm Hg (95% CI: 0.91; P < 0.05) and in patients with prior bimatoprost monotherapy (n = 18) from 16.4 ± 3.5 mm Hg (95% CI: 1.14) to 15.0 ± 3.3 mm Hg (95% CI: 1.14; P = 0.252). Both, objective clinical signs and subjective symptoms improved after changing medication to preservative-free tafluprost until final visit. The number of patients with moderate and severe hyperemia decreased from 51 (43.2%) at baseline to 2 (1.9%) at final visit.

Conclusion: Preservative-free tafluprost 0.0015% was effective, well tolerated and safe. IOP was controlled effectively and ocular symptoms and clinical signs were improved after changing medication to a monotherapy with preservative-free tafluprost in patients previously treated with a preserved latanoprost, travoprost or bimatoprost monotherapy.

No MeSH data available.


Related in: MedlinePlus

IOP in all individual patients (n = 118; 236 eyes) treated with prior PGA monotherapy at baseline versus final visit after change of medication to a monotherapy with preservative-free tafluprost 0.0015%.Abbreviations: IOP, intraocular pressure; PGA, prostaglandin analog.
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f3-opth-5-623: IOP in all individual patients (n = 118; 236 eyes) treated with prior PGA monotherapy at baseline versus final visit after change of medication to a monotherapy with preservative-free tafluprost 0.0015%.Abbreviations: IOP, intraocular pressure; PGA, prostaglandin analog.

Mentions: Overall mean IOP (±SD) was 16.2 ± 4.3 mm Hg (95% CI: 0.55) at treated baseline. Four to 6 weeks after changing medication, overall mean IOP was reduced to 15.0 ± 3.2 mm Hg (95% CI: 0.43), and after 12 weeks to 14.8 ± 3.2 mm Hg (95% CI: 0.43) (Figure 2). This IOP reduction is equivalent to 8.4% and 8.6% from treated baseline, respectively. At both 4 to 6 weeks and 12 weeks, overall treated IOP values were significantly lower than baseline values (P < 0.001). A reduction of mean IOP was also achieved for all different PGA compounds: In patients with prior latanoprost monotherapy (n = 68) mean IOP at baseline (±SD) was reduced from 16.2 ± 4.6 mm Hg (95% CI: 0.77) to 14.8 ± 3.1 mm Hg at final visit (95% CI: 0.54; P < 0.001); in patients with prior travoprost monotherapy (n = 32) from 16.2 ± 4.3 mm Hg (95% CI: 1.05) to 14.9 ± 3.3 mm Hg (95% CI: 0.91; P < 0.05); and in patients with prior bimatoprost monotherapy (n = 18) from 16.4 ± 3.5 mm Hg (95% CI: 1.14) to 15.0 ± 3.3 mm Hg (95% CI: 1.14; P = 0.252). In all patients with prior PGA monotherapy, IOP at final visit compared to baseline IOP was lower in 109 eyes (46.2%), equal in 51 eyes (21.6%) and higher in 76 eyes (32.2%) (Figure 3). In all patients with prior PGA monotherapy, preservative-free tafluprost 0.0015% provided IOP-values of ≤18 mm Hg for 83.1%, ≤16 mm Hg for 68.6%, ≤14 mm Hg for 51.7% and ≤12 mm Hg for 28.0% of all eyes. In the subset of patients (n = 24) who were switched from prior PGA monotherapy to preservative-free tafluprost due to efficacy reasons mean IOP was lowered significantly by −3.9 mm Hg (P < 0.001) compared to baseline. Individual IOP’s in those patients were lower at final visit compared to baseline in 28 eyes (58.2%), stayed the same in 12 eyes (25.0%) and were higher compared to baseline in 6 eyes (16.7%). In contrast IOP in two subsets of patients switched due to ocular signs (n = 31) and due to subjective symptoms (n = 41) a smaller effect on IOP reduction was observed (Table 2).


Switching patients from preserved prostaglandin-analog monotherapy to preservative-free tafluprost.

Hommer A, Kimmich F - Clin Ophthalmol (2011)

IOP in all individual patients (n = 118; 236 eyes) treated with prior PGA monotherapy at baseline versus final visit after change of medication to a monotherapy with preservative-free tafluprost 0.0015%.Abbreviations: IOP, intraocular pressure; PGA, prostaglandin analog.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3104790&req=5

f3-opth-5-623: IOP in all individual patients (n = 118; 236 eyes) treated with prior PGA monotherapy at baseline versus final visit after change of medication to a monotherapy with preservative-free tafluprost 0.0015%.Abbreviations: IOP, intraocular pressure; PGA, prostaglandin analog.
Mentions: Overall mean IOP (±SD) was 16.2 ± 4.3 mm Hg (95% CI: 0.55) at treated baseline. Four to 6 weeks after changing medication, overall mean IOP was reduced to 15.0 ± 3.2 mm Hg (95% CI: 0.43), and after 12 weeks to 14.8 ± 3.2 mm Hg (95% CI: 0.43) (Figure 2). This IOP reduction is equivalent to 8.4% and 8.6% from treated baseline, respectively. At both 4 to 6 weeks and 12 weeks, overall treated IOP values were significantly lower than baseline values (P < 0.001). A reduction of mean IOP was also achieved for all different PGA compounds: In patients with prior latanoprost monotherapy (n = 68) mean IOP at baseline (±SD) was reduced from 16.2 ± 4.6 mm Hg (95% CI: 0.77) to 14.8 ± 3.1 mm Hg at final visit (95% CI: 0.54; P < 0.001); in patients with prior travoprost monotherapy (n = 32) from 16.2 ± 4.3 mm Hg (95% CI: 1.05) to 14.9 ± 3.3 mm Hg (95% CI: 0.91; P < 0.05); and in patients with prior bimatoprost monotherapy (n = 18) from 16.4 ± 3.5 mm Hg (95% CI: 1.14) to 15.0 ± 3.3 mm Hg (95% CI: 1.14; P = 0.252). In all patients with prior PGA monotherapy, IOP at final visit compared to baseline IOP was lower in 109 eyes (46.2%), equal in 51 eyes (21.6%) and higher in 76 eyes (32.2%) (Figure 3). In all patients with prior PGA monotherapy, preservative-free tafluprost 0.0015% provided IOP-values of ≤18 mm Hg for 83.1%, ≤16 mm Hg for 68.6%, ≤14 mm Hg for 51.7% and ≤12 mm Hg for 28.0% of all eyes. In the subset of patients (n = 24) who were switched from prior PGA monotherapy to preservative-free tafluprost due to efficacy reasons mean IOP was lowered significantly by −3.9 mm Hg (P < 0.001) compared to baseline. Individual IOP’s in those patients were lower at final visit compared to baseline in 28 eyes (58.2%), stayed the same in 12 eyes (25.0%) and were higher compared to baseline in 6 eyes (16.7%). In contrast IOP in two subsets of patients switched due to ocular signs (n = 31) and due to subjective symptoms (n = 41) a smaller effect on IOP reduction was observed (Table 2).

Bottom Line: All adverse events were recorded.Preservative-free tafluprost 0.0015% was effective, well tolerated and safe.IOP was controlled effectively and ocular symptoms and clinical signs were improved after changing medication to a monotherapy with preservative-free tafluprost in patients previously treated with a preserved latanoprost, travoprost or bimatoprost monotherapy.

View Article: PubMed Central - PubMed

Affiliation: Sanatorium Hera, Vienna, Austria.

ABSTRACT

Purpose: Efficacy, tolerability and safety of the novel preservative-free prostaglandin tafluprost 0.0015% were investigated for the treatment of patients with glaucoma or ocular hypertension in a clinical setting.

Patients and methods: Data were collected in a non-interventional, prospective, multi-center, observational, open label study. 118 patients were treated with a prostaglandin analog (PGA) monotherapy (preserved formulations of latanoprost, travoprost or bimatoprost) prior to baseline. Intraocular pressure (IOP) readings were recorded for each eye at baseline (previous therapy), 4-6 weeks, and 12 weeks after changing medical treatment to preservative-free tafluprost once-daily. We analyzed the change in IOP over the study period for all patients as well as for a subgroup of patients with prior PGA monotherapy. Subjective symptoms and objective ocular signs were determined. Comfort was measured using a 4 step scale. All adverse events were recorded. Paired t-tests were conducted to compare IOP values at baseline to IOP values after treatment with tafluprost 0.0015%. Bowker's test of symmetry was used for statistical evaluation of changes of clinical signs (hyperemia).

Results: In total 118 patients were eligible for evaluation. In these patients with prior PGA monotherapy (n = 118) IOP decreased significantly from 16.2 ± 4.3 mm Hg (95% CI: 0.55) at treated baseline to 14.8 ± 3.2 mm Hg (95% CI: 0.43; P < 0.001) at final visit on tafluprost. In a subset of patients with prior latanoprost monotherapy (n = 68) mean IOP at baseline (±SD) was reduced from 16.2 ± 4.6 mm Hg (95% CI: 0.77) 14.8 ± 3.1 mm Hg at final visit (95% CI: 0.54, P < 0.001), in patients with prior travoprost monotherapy (n = 32) from 16.2 ± 4.3 mm Hg (95% CI: 1.05) to 14.9 ± 3.3 mm Hg (95% CI: 0.91; P < 0.05) and in patients with prior bimatoprost monotherapy (n = 18) from 16.4 ± 3.5 mm Hg (95% CI: 1.14) to 15.0 ± 3.3 mm Hg (95% CI: 1.14; P = 0.252). Both, objective clinical signs and subjective symptoms improved after changing medication to preservative-free tafluprost until final visit. The number of patients with moderate and severe hyperemia decreased from 51 (43.2%) at baseline to 2 (1.9%) at final visit.

Conclusion: Preservative-free tafluprost 0.0015% was effective, well tolerated and safe. IOP was controlled effectively and ocular symptoms and clinical signs were improved after changing medication to a monotherapy with preservative-free tafluprost in patients previously treated with a preserved latanoprost, travoprost or bimatoprost monotherapy.

No MeSH data available.


Related in: MedlinePlus