Nedocromil sodium and astemizole, alone or combined, for treatment of seasonal allergic conjunctivitis (SAC)

Abstract

SAC is caused by allergen interaction with IgE antibody on conjunctival mast cells, leading to local release of vasoactive inflammatory mediators such as histamine. Nedocromil sodium both stabilizes mast cells and has antiinflammatory activity against other cells involved in allergic inflammation. Astemizole is a second generation orally-active H(1)-receptor antagonist with reduced CNS effects such as drowsiness. This multicentre, double blind, double dummy trial compared efficacy and safety of qid 2% nedocromil sodium eye drops with once daily 10 mg oral astemizole, placebo, and combined active treatments for a four-week period. SAC patients (n=207, aged 6-70 years) recorded their symptoms each day on diary cards. Signs and symptoms were also evaluated by clinicians after one, two and four weeks and overall opinions were recorded at the end of treatment. Nedocromil sodium eye drops and astemizole, alone or combined, significantly reduced ocular symptoms compared to placebo (for diary card total symptom score and patients' opinion). Clinicians' opinion showed significantly decreased symptoms with nedocromil sodium, alone or combined, but not with astemizole alone. All treatments were well tolerated, with drowsiness the most frequent side effect observed in patients treated with astemizole. These results demonstrate the effectiveness of nedocromil sodium eye drops in the treatment of SAC.