Efficacy and safety of nedocromil sodium 2% ophthalmic solution b.i.d. in the treatment of ragweed seasonal allergic conjunctivitis

The efficacy and safety of twice-daily nedocromil sodium 2% ophthalmic solu tion and vehicle were compared in the treatment of ragweed seasonal allergi c conjunctivitis. Two separate multicenter, randomized, double-masked, plac ebo-controlled studies were subjected to a combined analysis. Following a o ne-week baseline period during the beginning of the ragweed pollen season, 189 patients with seasonal allergic conjunctivitis received either nedocrom il sodium or vehicle b.i.d. for eight weeks. Efficacy was evaluated by pati ent diary cares and clinical eye examinations. Safety was assessed by repor ts of adverse events. Compared with vehicle, nedocromil sodium produced sig nificantly greater decreases in summary symptom score (p = 0.005), itch (p = 0.005), tearing (p = 0.004), overall eye condition (p = 0.001), and clini cian-evaluated conjunctival edema (p = 0.018), and significantly better (p = 0.001), and patient (p = 0.001) opinions of treatment effectiveness at th e peak pollen period. Additionally, the superiority of nedocromil sodium co mpared to vehicle approached statistical significance in redness reduction (p = 0.087) and clinician-evaluated conjunctival injection (p = 0.087). The re were no serious treatment-related adverse events in either treatment gro up. In summary, nedocromil odium 2% ophthalmic solution b.i.d. was found to be effective and to have a favorable safety profile in the treatment of se asonal allergic conjunctivitis.