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M. Diestelhorst, M. Hellmich, D. Hochrainer, G. Roessler, A. Steinfeld, B. Zierenberg; The Ocular Bioavailability From a New Microspray MO. A Comparison With Conventional Eye Drops . Invest. Ophthalmol. Vis. Sci. 2006;47(13):457.
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© ARVO (1962-2015); The Authors (2016-present)
To study the ocular bioavailability of fluorescein from a new ocular Microspray (MO) in healthy volunteers compared with conventional fluorescein eye drops.
In a randomized, open–label study the bioavailability of fluorescein 0.17% (Alcon) from the MO (15 µl; 25 µg) was compared with a single drop (∼40µl; ∼68µg) from conventional bottles. The MO is modified from the Respimat® technology. A micro–mist (1–5µ) reaches the cornea at low velocity after being released by the patient. Bioavailability of cornea and anterior chamber was quantified by ocular fluorophotometry (Fluorotron Master II, Ocumetrics, USA) at baseline and +2–30, 60, 90, 120, 180, 240 minutes after application. Volunteers were naive to eye medication. One eye each was selected at random.
12 males and 8 females (mean age: 25.5±2.6 years; range: 21–32; 10 OD, 10 OS) finished the protocol. When adjusted for dose the MO showed a statistically significantly better bioavailability at cornea and anterior chamber (p=0.031). Handling: volunteers could apply fluorescein properly only via the MO. Earlier data of MO handling and tolerability were confirmed (ARVO 2005).
The bioavailability from the new micriospray ophtha was studied for the first time. The device demonstrated a significantly better drug delivery to the human ocular surface when adjusted for dose. The new Microspray ophtha is superior to eye drops from conventional bottles with regards to handling, tolerability and bioavailability. The MO will simplify topical therapy in ophthalmology and shall demonstrate to improve adherence.
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