Preservative free tafluprost 0.0015% in the treatment of patients with ocular hypertension and glaucoma: results of a multi‐center open‐label observational study

Abstract

Purpose Efficacy, tolerability and safety of the novel preservative‐free prostaglandin tafluprost 0.0015% were investigated. Methods Data were collected in a non‐interventional prospective multi‐center observational open label study. IOP readings were recorded for each eye at baseline (prior therapy or untreated) and 12 weeks after changing or initiating treatment with preservative‐free tafluprost. Change in IOP was evaluated over the study period for all patients and for specific pre‐treatment subgroups. Local comfort was measured using a 5 step scale. All adverse events were recorded. Results Data from 2123 patients with glaucoma or ocular hypertension were eligible for the final evaluation. In all patients preservative‐free tafluprost lowered IOP from 19.5+4.4 mmHg at baseline to 16.4+2.9 mmHg after 12 weeks. Preservative‐free tafluprost also lowered IOP significantly in all monotherapy‐subgroups: Naϊve patients (N=440): 22.6+3.9 mmHg to 16.7+2.7mmHg; betablockers (N=307): 20.3+3.5 mmHg (baseline) to 16.7+2.6 mmHg (week 12); CAI’s (N=158): 19.0+3.6 mmHg to 16.0+2.6 mmHg; PG’s (N=447): 16.8+2.9 mmHg to 15.8+2.6 mmHg. Local comfort was rated as 'very good' or 'good' by 85.6% of patients at the final visit. Only few adverse events occurred during the treatment period. Conclusion Preservative‐free tafluprost was effective, well tolerated and safe in a broad patient population. Local comfort and patient satisfaction improved after change of medical treatment in the vast majority of patients. Commercial interest