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

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.