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M. Diestelhorst, M. Hellmich, D. Hochrainer, G. Roessler, A. Steinfeld, B. Zierenberg; The Microspray: A New Ocular Drug Delivery Device . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2469.
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Purpose:To study the safety, tolerability and handling of a new Microspray (MS) in patients with glaucoma, dry–eye syndrome and in healthy volunteers. Methods: Patients with glaucoma or dry–eye syndrome applied one drop of a tear–film substitute (Sic–OphthalTM) from 10 ml bottles and via the MS to one eye each at random. The MS, based on the Respimat® technology, consists of droplets in the size range 1–5 µm, which reach the eye with a low velocity after being released by the patient. Safety, tolerability, handling and SE were qualified by VAS and questionnaire. In a second study 20 volunteers –naive to eye medication– applied Sic–OphthalTM via the MS and from the bottle for 5 consecutive days to each eye at random in a cross–over design. Results: 20 patients (12 females, 8 males; age: 69.5±11 years) who had used eye drops for 17.3 years (mean: 3.1 drops/day/eye; range: 1–9 drops) judged safety, tolerability and handling stat. significantly (p=0.000) in favor of the MS application. The experienced patients could apply one drop properly only via the MS. The volunteers confirmed these findings (p=0.000). VAS were stat. significantly in favor of the MS device (p=0.000). Conclusions: The Microspray was superior to the conventional bottle application with regards to safety, tolerability and handling by both the experienced patients and the naive volunteers. The Microspray shall simplify the treatment in ophthalmology and thereby increase the compliance. The bioavailability from the Microspray will be studied.
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