RT Journal Article
SR Electronic
T1 Clinical & biological efficacy of preservative-free NAAGA eye-drops versus levocabastine eye-drops in vernal keratoconjunctivitis patients
JF British Journal of Ophthalmology
JO Br J Ophthalmol
FD BMJ Publishing Group Ltd.
DO 10.1136/bjo.2007.117515
A1 Andrea Leonardi
A1 Dominique Bremond-Gignac
A1 Mauro Bortolotti
A1 Daniele Violato
A1 Pascale Pouliquen
A1 Laurent Delval
A1 Jean-Marie Grouin
A1 Iva Fregona
YR 2007
UL http://bjo.bmj.com/content/early/2007/06/21/bjo.2007.117515.abstract
AB Purpose: This comparative and randomised pilot study was to assess the clinical and biological efficacy of Naaxia Sine® eye-drops versus levocabastine eye-drops in the treatment of VKC. Methods: A total of 23 VKC patients were randomised and treated bilaterally for 28 days with NAAGA or levocabastine (LEVO) eye-drops. The primary efficacy variable, overall evolution of ECP tear concentrations, was assessed in a masked fashion on D0, D7 and D28. Clinical symptoms and signs were reported at the same time points. Biological parameters were analysed with a non-parametric rank-based approach. Global tolerance was assessed by the investigator and by the patient. Results: During all the study period, ECP tear-levels were significantly reduced in the NAAGA group compared to the LEVO group (p= 0.023). The reduction of eosinophil leukocytes and lymphocytes in tear was also higher in the NAAGA group although not significant. The same trend was observed for the evolution of total score of ocular symptoms. There were no significant differences between treatment groups in the occurrence of adverse effects, except for burning which was more frequent in the LEVO group (p= 0.002). Conclusion: The anti-eosinophilic actions of NAAGA are showed by a significant reduction of ECP tear concentrations. In addition, a decrease of lymphocyte count and an overall improvement of the symptomatology were noted. Moreover, treatment tolerability of NAAGA appeared better.