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In vitro and in vivo comparative toxicological study of a new preservative-free latanoprost formulation.
MedLine Citation:
PMID:  23150620     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSE: To compare in vitro, on the human reconstituted corneal epithelial SkinEthics model, and in vivo, using an acute rabbit toxicological model, the effects of a benzalkonium chloride (BAK)-preserved solution of latanoprost and a preservative-free (PF) latanoprost solution. METHODS: In vitro, the 3D reconstituted human corneal epithelia (HCE) were treated with: phosphate-buffered saline (PBS), BAK-latanoprost, PF-latanoprostor 0.02% BAK for 24h followed or not followed by a 24-h postincubation recovery period. Cellular viability was evaluated using the MTT test at 24h and the apoptotic cells were counted using TUNEL labeling on frozen sections at 24h and 24h+24h. In vivo, rabbits received 50 μl of the same solutions, which were applied at 5-min intervals a total of 15 times. Ocular surface toxicity was investigated using slit lamp biomicroscopy examination, conjunctival impression cytology (CIC), and corneal in vivo confocal microscopy (IVCM). Standard immunohistology also assessed inflammatory CD45-positive cells. RESULTS: In vitro, BAK-latanoprost and 0.02% BAK induced significant apoptosis in the apical layers that correlated with the significant decrease of cell viability as assessed by the MTT test. PF-latanoprost slightly decreased cell viability to 83% and few apoptotic cells were found in the superficial layers, without reaching statistical significance compared to PBS. In vivo, clinical observation and IVCM images showed the lowest ocular surface toxicity with PBS and PF-latanoprost, while BAK-latanoprost and BAK induced abnormal corneoconjunctival aspects. PF-latanoprost showed the lowest CIC score, close to the PBS score and induced fewer CD45-positive cells in both the limbus and the conjunctiva compared with BAK and latanoprost, as assessed by immunohistology. CONCLUSIONS: We confirm that rabbit corneoconjunctival surfaces presented better tolerance when treated with PF-latanoprost compared with the standard BAK-latanoprost preparation or the BAK solution.
Authors:
Aude Pauly; Christophe Roubeix; Hong Liang; Francoise Brignole-Baudouin; Christophe Baudouin
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-13
Journal Detail:
Title:  Investigative ophthalmology & visual science     Volume:  -     ISSN:  1552-5783     ISO Abbreviation:  Invest. Ophthalmol. Vis. Sci.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7703701     Medline TA:  Invest Ophthalmol Vis Sci     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Institut de la Vision, INSERM UMRS 968, UPMC Univ Paris 06, Paris, 75012, France.
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