Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Patients with Allergic Conjunctivitis and Tear Film Dysfunction: A Randomized Controlled Trial.

INTRODUCTION: Allergic conjunctivitis is a common ocular condition characterized by discomfort, itching, and redness, which significantly impacts quality of life. Its frequent overlap with dry eye disease (DED) complicates diagnosis and management, as both conditions share inflammation and tear film dysfunction as underlying mechanisms. Effective treatments must address both the inflammatory and tear film aspects of these conditions. While traditional therapies include antihistamines and mast cell stabilizers, innovative approaches focus on agents with dual anti-inflammatory and antiallergic properties. N-acetyl-aspartyl-glutamate (NAAGA) has shown potential in alleviating symptoms of both allergic conjunctivitis and DED through mechanisms involving mast cell stabilization, inhibition of inflammatory mediators, and improvement of tear film stability. This study compares the efficacy of NAAGA and azelastine hydrochloride, an established antihistamine, in improving symptoms and clinical markers of tear film dysfunction in patients with allergic conjunctivitis.

METHODS: This randomized, single-blind study included 134 patients with atopy and mild to moderate tear film dysfunction. Participants received either NAAGA (49 mg/ml, four times daily) or azelastine hydrochloride (0.05%, twice daily) for 4 weeks. The primary endpoint was the change in Ocular Surface Disease Index (OSDI) scores. Secondary endpoints included tear osmolarity, Schirmer test results, tear break-up time (TBUT), fluorescein staining, and matrix metalloproteinase-9 (MMP-9) levels.

RESULTS: Both treatments improved all parameters significantly over 4 weeks. NAAGA reduced OSDI scores from 26.12 ± 4.70 to 11.84 ± 3.43, compared to azelastine's improvement from 24.57 ± 4.70 to 15.54 ± 4.36 (p < 0.001). NAAGA showed superior reductions in tear osmolarity (from 320.99 ± 4.35 to 312.33 ± 3.25 mOsm/l) compared to azelastine (from 320.13 ± 3.46 to 318.57 ± 3.46 mOsm/l, p < 0.001), and greater enhancements in Schirmer test results (6.51 ± 1.95 mm to 10.08 ± 1.88 mm) and TBUT (4.10 ± 1.70 to 7.91 ± 1.79 s).

CONCLUSIONS: NAAGA outperformed azelastine in alleviating symptoms and improving clinical markers of tear film dysfunction in allergic conjunctivitis. Its dual action on inflammation and tear stability highlights its therapeutic potential. Further studies are warranted to confirm these findings and explore additional applications.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT12345678.