May 2006
Volume 47, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2006
The Ocular Bioavailability From a New Microspray MO. A Comparison With Conventional Eye Drops
Author Affiliations & Notes
  • M. Diestelhorst
    University of Cologne, Cologne, Germany
    Department Ophthalmology,
  • M. Hellmich
    University of Cologne, Cologne, Germany
    IMSIE,
  • D. Hochrainer
    Boehringer Ingelheim, Ingelheim, Germany
  • G. Roessler
    Department Ophthalmology, University of Aachen, Aachen, Germany
  • A. Steinfeld
    Department Ophthalmology, University of Aachen, Aachen, Germany
  • B. Zierenberg
    Boehringer Ingelheim, Ingelheim, Germany
  • Footnotes
    Commercial Relationships  M. Diestelhorst, Boehringer, Germany, P; M. Hellmich, None; D. Hochrainer, Boehringer, Germany, P; G. Roessler, None; A. Steinfeld, None; B. Zierenberg, Boehringer, Germany, P.
  • Footnotes
    Support  Restricted grant Boehringer Ing.
Investigative Ophthalmology & Visual Science May 2006, Vol.47, 457. doi:
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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)

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Abstract

Purpose: : To study the ocular bioavailability of fluorescein from a new ocular Microspray (MO) in healthy volunteers compared with conventional fluorescein eye drops.

Methods: : 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.

Results: : 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).

Conclusions: : 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.

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • drug toxicity/drug effects • pharmacology 
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