Clinical & biological efficacy of preservative-free NAAGA eye-drops versus levocabastine eye-drops in vernal keratoconjunctivitis patients
- Andrea Leonardi (andrea.leonardi{at}unipd.it),
- Dominique Bremond-Gignac (dominique.bremond{at}rdb.ap-hop-paris.fr),
- Mauro Bortolotti (bortolottim{at}orsola-malpighi.med.unibo.it),
- Daniele Violato,
- Pascale Pouliquen (p.pouliquen{at}laboratoires-thea.fr),
- Laurent Delval (l.delval{at}laboratoires-thea.fr),
- Jean-Marie Grouin (grouin2{at}wanadoo.fr),
- Iva Fregona
- University of Padua, Italy
- Hôpital Robert Debré, France
- University of Padua, Italy
- University of Padua, Italy
- Laboratoires Théa, France
- Laboratoires Théa, France
- University of Rouen, France
- University of Padua, Italy
- Published Online First 21 June 2007
Abstract
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.
