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RESEARCH PRODUCT

Changes in ocular signs and symptoms when switching from preserved latanoprost 0.005% to preservative-free tafluprost 0.0015%: phase IIIb study in patients with open-angle glaucoma or ocular hypertension

subject

description

Purpose This open-label, multinational, phase IIIb study investigated the changes in ocular signs and symptoms when patients were switched from preserved latanoprost 0.005% to preservative-free tafluprost 0.0015% (q.d. at 20:00) for 12 weeks. Methods Patients with open-angle glaucoma or ocular hypertension who had received latanoprost for at least 6 months and had at least 2 ocular symptoms or one symptom and one sign were enrolled (n=158). Change from screening in ocular symptoms and signs were the main endpoints. Data from the 6-week analysis are reported here. Results After switching to preservative-free tafluprost, the proportion of patients with at least mild symptoms decreased: irritation/burning/stinging sensation 56.3% to 30.8%, foreign body sensation 46.8% to 25.6%, tearing 49.4% to 28.8%, itching 55.1% to 25.6% and dry-eye sensation 64.6% to 35.3%. Decreases in proportions for abnormal signs were: tear break-up time 94.9% to 76.9%, corneal fluorescein staining 81.6% to 52.6%, conjunctival fluorescein staining 84.2% to 53.8%, blepharitis 60.1% to 42.3%, conjunctival hyperaemia 84.2% to 69.2% and tear production 71.5% to 61.5%. All changes were statistically significant. Conclusion Switching patients from preserved latanoprost to preservative-free tafluprost clearly reduced ocular symptoms and signs. Commercial interest ERRATA SHEET Correction to order of ocular symptoms and respective values for percentage of patients with abnormal values: After switching to preservative-free tafluprost, the proportion of patients with at least mild symptoms decreased: irritation/burning/stinging sensation 56.3% to 30.8%, itching 46.8% to 25.6%, foreign body sensation 49.4% to 28.8%, tearing 55.1% to 25.6% and dry-eye sensation 64.6% to 35.3%. [Correction added after online publication 4 Sept. 2008]