Long term safety and tolerability of Tafluprost 0.0015% vs Timolol 0.1% preservative-free in ocular hypertensive and in primary open-angle glaucoma patients: a cross sectional study

• Published in: BMC ophthalmology Vol. 17; no. 1; pp. 136 - 8
• Main Authors: Rolle, Teresa, Spinetta, Roberta, Nuzzi, Raffaele
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 03.08.2017; BioMed Central; BMC
• Subjects: Aged; Antihypertensive Agents - administration & dosage; Beta blockers; Cataracts; Comparative analysis; Confocal microscopy; Cornea; Cross-Sectional Studies; Dose-Response Relationship, Drug; Drug therapy; Drug Tolerance; Epithelial cells; Eye surgery; Female; Follow-Up Studies; Glaucoma; Glaucoma, Open-Angle - drug therapy; Glaucoma, Open-Angle - physiopathology; Health aspects; Humans; Hypertension; In vivo confocal microscopy; Intraocular pressure; Intraocular Pressure - drug effects; Kruskal-Wallis test; Lasers; Male; Microscopy; Microscopy, Confocal; Middle Aged; Nerves; Ocular Hypertension - drug therapy; Ocular Hypertension - physiopathology; Ocular surface; Open-angle glaucoma; Ophthalmic Solutions; Ophthalmology; Preservatives; Preservatives, Pharmaceutical; Primary open angle glaucoma; Prostaglandins F - administration & dosage; Questionnaires; Side effects; Tafluprost; Tears - chemistry; Time Factors; Timolol; Timolol - administration & dosage; Timolol maleate; Timolol preservative free; Tonometry, Ocular; Trauma; Treatment Outcome; Tafluprost; Ocular surface; In vivo confocal microscopy; Primary open angle glaucoma; Timolol preservative free
• ISSN: 1471-2415; 1471-2415
• DOI: 10.1186/s12886-017-0534-z

The effects of preservatives of antiglaucoma medications on corneal surface and tear function have been widely shown in literature; it's not the same as regards the active compounds themselves. The purpose of our study was to compare Ocular Surface Disease (OSD) signs and symptoms of Tafluprost 0.0015% versus preservative free (PF) Timolol 0.1% eyedrops in ocular hypertensive (OH) and in primary open-angle glaucoma (POAG) patients. A cross-sectional study included patients in monotherapy for at least 36 months with Tafluprost 0.0015% (27) or PF Timolol 0.1% (24) and 20 healthy age and sex-matched volunteers. All subjects underwent clinical tests (Schirmer I and break-up time), in vivo confocal microscopy (IVCM) and were surveyed using Ocular Surface Disease Index (OSDI) and Glaucoma Symptoms Scale (GSS) questionnaires. The groups were compared with ANOVA, Kruskal-Wallis test, t-test, Mann-Whitney test and Bonferroni's adjustment of p-values. No significant differences were found in questionnaires scores, clinical tests, IVCM variables between therapy groups. Tafluprost 0.0015% group showed significantly higher OSDI score, basal epithelial cells density, stromal reflectivity, sub-basal nerves tortuosity (p = 0.0000, 0.037, 0.006, 0.0000) and less GSS score, number of sub-basal nerves (p = 0.0000, 0.037) than controls but similar clinical tests results (p > 0.05). PF Timolol group had significantly higher OSDI score, basal epithelial cells density, stromal reflectivity and sub-basal nerve tortuosity (p = 0.000, 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. Compared to PF Timolol 0.1%, Tafluprost 0.0015% showed similar safety with regards to tear function and corneal status and a similar tolerability profile. Both therapy groups show some alterations in corneal microstructure but no side effects on tear function except for an increased tear instability in PF Timolol 0.1% group. Ophtalmologists should be aware that even PF formulations may lead to a mild ocular surface impairment.