[Evaluation of NAAGA efficacy in dry eye syndrome].

Abstract

OBJECTIVES:

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

PATIENTS AND 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.

CONCLUSION:

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.

• Authors: F Brignole-Baudouin, P-Y Robert, C Creuzot-Garcher, C Olmiere, L Delval, C Baudouin
• Journal: Journal francais d'ophtalmologie (J Fr Ophtalmol) Vol. 32 Issue 9 Pg. 613-20 (Nov 2009) ISSN: 1773-0597 [Electronic] France
• Vernacular Title: Evaluation de l'efficacité du NAAGA dans la sécheresse oculaire.
• PMID: 19854539 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Allergic Agents
• Anti-Inflammatory Agents, Non-Steroidal
• Dipeptides
• HLA-DR Antigens
• MUC5AC protein, human
• Mucin 5AC
• Ophthalmic Solutions
• Preservatives, Pharmaceutical
• isospaglumic acid

Topics

• Adult
• Aged
• Aged, 80 and over
• Anti-Allergic Agents (administration & dosage, therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, therapeutic use)
• Blepharitis (complications, drug therapy)
• Dipeptides (administration & dosage, therapeutic use)
• Double-Blind Method
• Dry Eye Syndromes (complications, drug therapy)
• Female
• Gene Expression (drug effects)
• HLA-DR Antigens (biosynthesis, genetics)
• Humans
• Instillation, Drug
• Male
• Middle Aged
• Mucin 5AC (biosynthesis, genetics)
• Ophthalmic Solutions (therapeutic use)
• Pilot Projects
• Preservatives, Pharmaceutical (administration & dosage)