April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Efficacy Study Of An Unpreserved Liposomal Formulation In A Dry Eye Animal Model
Author Affiliations & Notes
  • Marta Vicario
    Pharmacy & Pharmaceutical Technology, School of Pharmacy, Complutense University, Madrid, Spain
  • Laura Morales
    Superficie e Inflamación Ocular, Hospital Clínico San Carlos, Complutense University, Madrid, Spain
  • Eva Vico
    Superficie e Inflamación Ocular, Hospital Clínico San Carlos, Complutense University, Madrid, Spain
  • José Manuel Benítez-del-Castillo
    Superficie e Inflamación Ocular, Hospital Clínico San Carlos, Complutense University, Madrid, Spain
  • Manuel Guzmán
    Pharmacy & Pharmaceutical Technology, School of Pharmacy, University of Alcalá de Henares, Alcalá de Henares, Spain
  • Vanessa Andrés-Guerrero
    Pharmacy & Pharmaceutical Technology, School of Pharmacy, Complutense University, Madrid, Spain
  • Rocío Herrero-Vanrell
    Pharmacy & Pharmaceutical Technology, School of Pharmacy, Complutense University, Madrid, Spain
  • Irene T. Molina-Martínez
    Pharmacy & Pharmaceutical Technology, School of Pharmacy, Complutense University, Madrid, Spain
  • Footnotes
    Commercial Relationships  Marta Vicario, None; Laura Morales, None; Eva Vico, None; José Manuel Benítez-del-Castillo, None; Manuel Guzmán, None; Vanessa Andrés-Guerrero, None; Rocío Herrero-Vanrell, None; Irene T. Molina-Martínez, None
  • Footnotes
    Support  FIS PI07/0043 and PI070012 and Research Group UCM 920415 (GR58/09).
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 3773. doi:
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      Marta Vicario, Laura Morales, Eva Vico, José Manuel Benítez-del-Castillo, Manuel Guzmán, Vanessa Andrés-Guerrero, Rocío Herrero-Vanrell, Irene T. Molina-Martínez; Efficacy Study Of An Unpreserved Liposomal Formulation In A Dry Eye Animal Model. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3773.

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Abstract

Purpose: : Artificial tears are employed in order to minimize the signs and symptoms of Dry Eye Syndrome. There is a great interest related to the development of formulations that contain similar preocular tear film’s (PTF) components. The aim of this work was to determinate the efficacy of an optimized unpreserved formulation based on liposomes destined to replace the PTF. This formulation was composed by lipid components (liposomes) dispersed in a hypotonic solution of borates, trehalose and hyaluronic acid (0.2%).

Methods: : The formulation was tested in a dry eye model (instillation of an isotonic solution of Benzalkonium Chloride (BAK) 0.1% twice a day during 15 days in New Zealand rabbits). The protocol described was in accordance with the ARVO Statement for the Use in Animals and Ophthalmology Vision Research. The animals (n=8) received 60 µl of the liposomal formulation four times per day for 15 days in the right eye. As control, an isotonic solution of sodium chloride was instilled in the contralateral eye. Fluorescein staining, impression cytology and osmolarity (TearLab®) were used to evaluate the ocular surface throughout the entire study (30 days).

Results: : At the end of treatment with BAK (15 days), fluorescein staining resulted to be positive for all the animals, the number of conjunctival goblet cells had decreased (26.0±16.1 goblet cells/100 epithelial cells) and the osmolarity values had increased to hipertonicity (323±14.9 mOsm/l). After the administration of the liposomal formulation fluorescein staining remained positive, the number of conjunctival goblet cells increased (43.0±4.1 goblet cells/100 epithelial cells) and osmolarity of tears decreased to physiological values (303±11.6 mOsm/l).

Conclusions: : The unpreserved liposomal formulation resulted to be effective in the dry eye animal model in terms of an increase of goblet cells number. The osmolarity of tears recovered to physiological values.

Keywords: cornea: tears/tear film/dry eye • ocular irritancy/toxicity testing • pathology: experimental 
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