Inventi Impact: Ophthalmology

Inventi:hotm/24383/17

Long Term Safety and Tolerability of Tafluprost 0.0015% vs Timolol 0.1% Preservative-Free in\nOcular Hypertensive and in Primary Open-Angle Glaucoma Patients: A Cross Sectional Study

Background: The effects of preservatives of antiglaucoma medications on corneal surface and tear function have\nbeen widely shown in literature; it�s not the same as regards the active compounds themselves. The purpose of our\nstudy was to compare Ocular Surface Disease (OSD) signs and symptoms of Tafluprost 0.0015% versus preservative\nfree (PF) Timolol 0.1% eyedrops in ocular hypertensive (OH) and in primary open-angle glaucoma (POAG) patients.\nMethods: A cross-sectional study included patients in monotherapy for at least 36 months with Tafluprost 0.0015%\n(27) or PF Timolol 0.1% (24) and 20 healthy age and sex-matched volunteers. All subjects underwent clinical tests\n(Schirmer I and break-up time), in vivo confocal microscopy (IVCM) and were surveyed using Ocular Surface Disease\nIndex (OSDI) and Glaucoma Symptoms Scale (GSS) questionnaires. The groups were compared with ANOVA,\nKruskal-Wallis test, t-test, Mann-Whitney test and Bonferroni�s adjustment of p-values.\nResults: No significant differences were found in questionnaires scores, clinical tests, IVCM variables between\ntherapy groups. Tafluprost 0.0015% group showed significantly higher OSDI score, basal epithelial cells density,\nstromal reflectivity, sub-basal nerves tortuosity (p = 0.0000, 0.037, 0.006, 0.0000) and less GSS score, number of\nsub-basal nerves (p = 0.0000, 0.037) than controls but similar clinical tests results (p > 0.05). PF Timolol group\nhad significantly higher OSDI score, basal epithelial cells density, stromal reflectivity and sub-basal nerve tortuosity (p = 0.\n000, 0.014, 0.008, 0.002), less GSS score, BUT and number of sub-basal nerves (p = 0.0000, 0.026, 0.003) than controls.\nConclusions: Compared to PF Timolol 0.1%, Tafluprost 0.0015% showed similar safety with regards to tear function and\ncorneal status and a similar tolerability profile. Both therapy groups show some alterations in corneal microstructure but\nno side effects on tear function except for an increased tear instability in PF Timolol 0.1% group. Ophtalmologists should\nbe aware that even PF formulations may lead to a mild ocular surface impairment