Studies comparing the efficacy of nedocromil sodium eye drops with sodium cromoglycate and placebo in seasonal allergic conjunctivitis.

ABSTRACT

Two multicentre, double-blind, placebo controlled group comparative studies were carried out in Finland, during the birch pollen seasons of 1987 and 1989, to compare the efficacy and tolerability of 2% nedocromil sodium eye drops (twice daily) with either 2% sodium cromoglycate eye drops (four times daily) and/or placebo, in patients with seasonal allergic conjunctivitis. Study 1 compared nedocromil sodium (64 patients) with placebo (62 patients) and showed that the opinions of treatment efficacy of both patients and clinicians were significantly in favour of nedocromil sodium (p = 0.003, patients; p = 0.006, clinicians). In addition, the placebo group used significantly more topical (p<0.05) and oral (p<0.01) concomitant antihistamine therapy. Diary card scores and clinical assessments showed trends for active treatment. Study 2 compared nedocromil sodium (60 patients) with sodium cromoglycate (61) and placebo (64). Symptomatology was low, in general, but patient diary card scores showed significant control of itching by both active treatments. Clinical assessments also showed some improvement with both active treatments, reaching statistical significance for grittiness and photophobia. Overall opinions demonstrated a high placebo effect. At the end of the trial, full or moderate control of symptoms was reported by 80% of patients (73% clinicians) receiving nedocromil sodium, 75% of patients (74% clinicians) receiving sodium cromoglycate and 73% of patients (69% clinicians) receiving placebo. Taken as a whole, these results suggest that twice-daily nedocromil sodium eye drops are as efficacious as four times daily sodium cromoglycate eye drops in controlling seasonal allergic conjunctivitis.