[Evaluation of NAAGA efficacy in dry eye syndrome].
OBJECTIVE
The aim of this study was to assess the efficacy of Naabak((R)) eyedrops in reducing inflammation in dry eye syndrome.


METHODS
This pilot, multicenter, randomized, double-blind, parallel study was carried out in adult patients suffering from moderate dry eye syndrome. Patients were treated for three months with preservative-free NAAGA (Naabak((R))) or with sodium chloride 0.9% without preservative (Larmabak(R)). They received the treatment four to six times a day during the 1(st) month and three to four times a day during the 2(nd) and 3(rd) months. At each visit (D28 and D84), clinical tests were performed as well as a biological evaluation of HLA-DR and MUC5AC expression on conjunctival imprints using flow cytometry.


RESULTS
After three months of treatment, the ocular surface symptoms and overall discomfort were improved in patients treated with Naabak(R) and in those treated with Larmabak(R) with no significant difference between the groups. Cytological impression showed a significant decrease in the expression of inflammatory markers, notably antigen HLA-DR, in the Naabak(R) group.


CONCLUSIONS
This study confirms the anti-inflammatory property of preservative-free NAAGA (Naabak(R)) in the context of dry eye syndrome with a similar clinical efficacy compared to sodium chloride solution (Larmabak(R)). Naabak(R) could present an additional advantage compared to artificial tears and could be indicated in the treatment of moderate inflammatory dry eye syndrome.
Centre National d'Ophtalmologie des Quinze-Vingts et UMR_S INSERM 968, Institut de la Vision, Université Paris 6, Paris.
F
F
Brignole-Baudouin
P-Y
PY
Robert
C
C
Creuzot-Garcher
C
C
Olmiere
L
L
Delval
C
C
Baudouin
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D001762:Blepharitis / Q000150:complications / Q000188:drug therapy; D004151:Dipeptides / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000150:complications / Q000188:drug therapy*; D005260:Female; D015870:Gene Expression / Q000187:drug effects; D006684:HLA-DR Antigens / Q000096:biosynthesis / Q000235:genetics; D006801:Humans; D007322:Instillation, Drug; D008297:Male; D008875:Middle Aged; D055271:Mucin 5AC / Q000096:biosynthesis / Q000235:genetics; D009883:Ophthalmic Solutions / Q000627:therapeutic use; D010865:Pilot Projects; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage
D018926:Anti-Allergic Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004151:Dipeptides; D006684:HLA-DR Antigens; C524678:MUC5AC protein, human; D055271:Mucin 5AC; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; C027172:isospaglumic acid