Purchase this article with an account.
P. Pouliquen, M. Bortolotti, I. Fregona, L. Delval, D. Violato, A. Leonardi; Clinical and Biological Efficacy of NAAXIA SINE in Vernal Keratoconjunctivitis Patients . Invest. Ophthalmol. Vis. Sci. 2006;47(13):4989.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To assess the clinical and biological efficacy of preservative–free N–acetyl–aspartyl–glutamate (NAAGA= NAAXIA SINE in ABAK system®) eye drops in the treatment of vernal keratoconjunctivitis (VKC) patients compared to the activity of levocabastine eye drops.
23 active VKC patients were enrolled from one center in a randomized, comparative, parallel–group pilot study. Subjects were treated for 28 days with levocabastine (LEVO) eye drops qid, or with NAAGA 6 times/day. On D0, D7 and D28, symptoms (itching, tearing, photophobia, foreign body sensation) and signs (redness, chemosis, discharge, papillae, limbal infiltrates, corneal epithelial disease) were evaluated. At the same time points, tears were collected for the measurement of eosinophil cationic protein (ECP; µg/L) and for cytology (N/µl). The primary efficacy variable, overall evolution of ECP tear levels, was assessed in a masked fashion. Secondary efficacy variables were the number of eosinophils and neutrophils in tears, evolution of the global clinical score (sum of scores for signs and symptoms: 0–38), and the use of adjuvant topical corticosteroids. Results between groups were compared by a non–parametric mixed ANOVA model for repeat measures.
Tear ECP levels were more significantly reduced in the NAAGA group than in the LEVO group at all time points in the study (p<0.0001). This finding was verified by the significantly lower numbers of eosinophils (p<0.005), neutrophils (p=0.05) and epithelial cells (p<0.01) in the NAAGA group compared with LEVO. This biological efficacy correlated with clinical signs indicated by improvement of the global clinical score and the total score of ocular symptoms. A steroid sparing effect was also noted in the NAAGA group. More burning sensation upon instillation was noted in the LEVO group at Day 7 (p<0.002).
Frequent administration of the preservative–free antiallergic agent, NAAGA, is effective in reducing the signs and symptoms of VKC and conjunctival inflammation. NAAGA’s significant effects on tear ECP indicate a possible inhibitory effect on eosinophil activation.
This PDF is available to Subscribers Only