RESUMEN
PURPOSE: To record the impact of preservative-free Tafluprost on corneal status examined by in vivo confocal microscopy. METHODS: A prospective cohort study on consecutive naïve or previously treated patients with a new prescription of preservative-free Tafluprost. All subjects underwent a complete ophthalmic examination [comprehensive of intraocular pressure (IOP) and central corneal thickness (CCT) measurements], and an in vivo corneal confocal microscopy evaluation, at baseline and 12 months later. A healthy control group was selected and examined at the same time. RESULTS: Seventy-five subjects (16 controls, 20 naïve, and 39 treated) were enrolled. At baseline, IOP was 16 (13.8-18.6), 21.5 (18-23.7), and 18 (16-22) mmHg, (P=0.01); and CCT did not differ among the groups (P=0.25). Epithelial cells, keratocyte activation, a number of sub-basal nerves, and the grade of nerve tortuosity were similar (P=0.233, 0.11, 0.417, and 0.05, respectively), in naïve and controls, while previously treated patients had significantly less epithelial cells and sub-basal corneal nerves (P<0.0001), keratocyte activation, increased number of bead-like formations, and nerve tortuosity (P<0.0001). At month 12, IOP decreased in both patient groups (P<0.001); CCT did not change. Previously treated patients showed an improvement in confocal parameters: increased epithelial cells (P=0.0006), reduced keratocyte activation (P=0.003), increased number of corneal nerves (P=0.0004), decreased number of bead-like formations (P=0.0013), and nerve tortuosity (P=0.0008). Naïve patients did not show significant changes. CONCLUSION: The study confirmed the efficacy of preservative-free Tafluprost in reducing IOP, and underlined the drug's safety in naïve glaucoma patients with regard to corneal status. In the balance between efficacy and tolerability, formulations with low cytotoxicity may ensure fewer side effects, with higher tolerability and better compliance.
Asunto(s)
Antihipertensivos/uso terapéutico , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Hipertensión Ocular/tratamiento farmacológico , Prostaglandinas F/uso terapéutico , Administración Oftálmica , Anciano , Antihipertensivos/administración & dosificación , Antihipertensivos/efectos adversos , Estudios de Casos y Controles , Estudios de Cohortes , Córnea/efectos de los fármacos , Córnea/inervación , Córnea/metabolismo , Queratocitos de la Córnea/efectos de los fármacos , Queratocitos de la Córnea/metabolismo , Endotelio Corneal/efectos de los fármacos , Endotelio Corneal/metabolismo , Femenino , Estudios de Seguimiento , Humanos , Presión Intraocular/efectos de los fármacos , Masculino , Microscopía Confocal , Persona de Mediana Edad , Estudios Prospectivos , Prostaglandinas F/administración & dosificación , Prostaglandinas F/efectos adversos , Método Simple CiegoRESUMEN
OBJECTIVES: The aim of this study was to evaluate the safety of preservative-free tafluprost in newly diagnosed patients and to confirm its efficacy in lowering intraocular pressure (IOP). METHODS: Naïve patients were submitted to an ophthalmic examination, including ocular surface status and quality of life evaluation. All examinations were performed at baseline and after 1 and 6 months. RESULTS: 28 patients were enrolled and treated with tafluprost, once a day, in the evening. TF-BUT changed from 9 (interquartile range (IQR) 6 - 11) s at baseline to 10 (IQR 7 - 10) s at 1 month (p = 0.106) and 9 (IQR 6 - 12) s at 6 months (p = 0.003). No eye developed corneal staining. Quality of life was (median (IQR)) 91.6 (79.2 - 95.8) at baseline and 95.8 (66.7 - 100) at 6 months (p = 0.62). Only a few adverse events occurred during the follow-up period (three patients experienced ocular burning and one developed redness). The mean IOP reduction was 5.5 mm Hg (95% CI 3.8 - 7.2). The median (IQR) baseline IOP was 18.7 (15 - 23.7) mm Hg; 14 (13 - 16) mm Hg and 16 (14 - 16) mm Hg (p < 0.0001) after 1 and 6 months, respectively. CONCLUSION: No patient developed ocular surface disease and quality of life perception was preserved. Preservative-free tafluprost is therefore an effective drug that is safe for the ocular surface after 6 months of daily therapy.