Comparison of topical nedocromil sodium and oral terfenadine for the treatment of seasonal allergic conjunctivitis.

This double-masked, comparative, multicenter study was conducted to assess the onset of action and tolerability of nedocromil sodium 2% ophthalmic solution BID, 60-mg terfenadine tablets BID, and placebo in the treatment of seasonal allergic conjunctivitis. Two hundred sixty-eight patients in whom seasonal allergic conjunctivitis was diagnosed were assigned to 1 of 3 groups and administered study medication for 4 weeks. Patients' mean age was 33 years (range, 12 to 68 years); 57.8% (155 of 268) were female. Demographic characteristics were similar in all 3 groups. Although all 3 groups showed improvement in ocular symptoms, nedocromil sodium was associated with a statistically significantly faster onset of action than was terfenadine or placebo (P = 0.038). During the study, 29 nedocromil sodium-treated patients (36.7%) achieved control of symptoms in < or =2 minutes, and 61 (77.2%) achieved control in < or =15 minutes. The corresponding numbers were 21 (24.7%) and 50 (58.8%) in the terfenadine group and 25 (29.1%) and 48 (55.8%) in the placebo group. The frequency of adverse events was low and similar between groups (nedocromil sodium, 26; terfenadine, 32; placebo, 32). No severe treatment-related adverse events were reported. In conclusion, nedocromil sodium had a significantly faster onset of action than did terfenadine or placebo.