Posters

Spaglumic acid 49 mg/ml (NAAGA) versus antihistamine eye drops (Azelastine hydrochloride 0,5 mg/ml) in allergic subjects with tear film dysfunction: clinical and biological evaluation

Poster Details

First Author: S.Troisi ITALY

Co Author(s):    S. Cirillo   M. Troisi   V. Turco              

Abstract Details

Purpose:

Allergic eye inflammations are often associated with tear film dysfunction. The purpose of this prospective randomized single blind study is to evaluate the impact of a topical non-steroidal antiallergic therapy on the symptoms and signs of dry eye and on the inflammatory state, using two different topical treatments: membrane stabilizer (NAAGA) and antihistamine eye drops (Azelastine hydrochloride).

Setting:

Ophthalmologic Unit of Salerno Hospital University, Center of Ocular Surface Pathology. Ethics Committee approval was obtained (authorization n. 31/2019).

Methods:

Consecutive atopic patients with symptoms of ocular discomfort (OSDI score ≥13) and mild/moderate dry eye are evaluated. Patients are randomized into two groups: Group A, treated with Spaglumic acid eyedrops 4,9% x 4/day; Group B, treated with antihistamine eyedrops (Azelastine hydrochloride0.05% x 2/day). Patients that match with the inclusion criteria were examinated at presentation and after 4 weeks of therapy with biomicroscopy and the following tests in each eye: OSDI, tear osmolarity,Schirmer I,TBUT, fluorescein corneo-conjunctival staining (CLEK-scheme), InflammaDry® (RPS,USA) for MMPs9. After 2 weeks OSDI, Schirmer test, TBUT and corneal staining evaluation was performed.The results were subjected to statistical analysis.

Results:

144 eyes of 72 patients (40 males , 32 females) were included (average age 29 years +/- 5). 74 eyes were treated with Spaglumic acid 49 mg/ml (group A), 70 with Azelastine hydrochloride eyedrops 0.5 mg/ml (group B). The results show in the Group A a statistically significant improvement (P minus of 0,01) of the OSDI score (from 26 to 11) and tear osmolarity values (from 321 to 312) compared to Group B (24 to 17 and 319 to 318 respectively) after 4 weeks of treatment. In parallel, there was a evident improvement of TBUT (4,2 sec.to 7,1 sec), CLEK score (1,7 to 0,3) and Schirmer test (7 to 10 mm) in patients treated with NAAGA compared with Group B (TBUT: 5,2 sec. to 5,7 sec.; CLEK: 1,8 to 1,2; no change of Schirmer). Finally we found a negative test for MMPs in 9/18 positive in group A and in 4/16 positive in group B

Conclusions:

NAAGA-treated eyes showed a significant improvement in discomfort symptoms (OSDI, P minus of 0.01), tear parameters (TBUT and Schirmer I, P minus of 0.05) and corneal epithelial staining (CLEK score, P minus of 0.01) compared to eyes treated with Azelastine hydrochloride. Finally, a greater percentage of eyes in group A (50%) became negative on the MMPs test compared to group B (25%). Dry eye patients seem to report greater benefits from topical membrane stabilizer therapy than antihistamine eye drops. Further studies on these and other drugs from these categories of antiallergic eye drops are needed to confirm these data.

Financial Disclosure:

None