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Paolo Frezzotti, Michele Figus, Carlo Cagini, Ilaria Motolese, Chiara Posarelli, Anna Bartolini, Simone Alex Bagaglia, Alessandra De Carolis, Eduardo Motolese; Efficacy, safety, and improved tolerability of preservative-free timolol 0.1% gel formulation compared with prior a BAK-preserved therapy. Invest. Ophthalmol. Vis. Sci. 2013;54(15):453.
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To evaluate the efficacy, safety and tolerability of switching to preservative-free timolol 0.1% gel patients with primary open-angle glaucoma or ocular hypertension previously treated with a BAK-preserved therapy to lower their intraocular pressure
Patients treated with a BAK-preserved therapy who needed alternative therapy due to tolerability issues were enrolled. Clinical tests (IOP, Schirmer I test, and lacrimal film break-up time BUT) and in vivo conjunctival confocal microscopy (IVCM) were performed in all patients at baseline and after 3 months. IVCM (HRT II Rostock Cornea Module; Heidelberg Engineering GmbH, Heidelberg, Germany) was performed after topical anaesthesia. The main IVCM outcomes were goblet cell density and epithelial regularity. Patients were surveyed using the Ocular Surface Disease Index (OSDI) to evaluate OSD symptoms prior to changing preservative-free timolol 0.1% gel dosed once every morning. Patients were re-evaluated 3 months later.
In 65 patients preservative-free timolol 0.1% gel improved mean OSDI scores compared to either BAK-preserved therapy (p < 0.0001). Patients having any baseline OSD symptoms (n = 65) demonstrated significant improvement after switching to preservative-free timolol 0.1% gel (p < 0.0001). A significant improvement in clinical scores (Schirmer I and BUT) was found between groups on preserved topical hypotensive therapy and the preservative-free timolol 0.1% gel. In 75.3% of these patients, symptoms were reduced in severity. IVCM parameters after 3months: intraepithelial goblet cell density was significantly improved in preservative-free timolol 0.1% gel (86.83 ± 22.17, p<0.001) than in the BAK-preserved therapy (48.25 ± 7.70, p<0.001) The epithelial layer was significantly more regular in preservative-free timolol 0.1% gel (0.75 ± 0.6 1) than in the BAK-preserved therapy (0.87 ± 0.6, p<0.001)
Patients previously treated with a BAK-preserved therapy who are changed to preservative-free timolol 0.1% gel have clinically and statistically significant improvement in their ICVM parameters, and OSD symptoms
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