A double-blind group comparative study of ophthalmic sodium cromoglycate, 2% four times daily and 4% twice daily, in the treatment of seasonal allergic conjunctivitis.

Abstract

In a multicenter, double-blind, single-dummy, group-comparative study, 169 patients received ophthalmic sodium cromoglycate 2% four times daily, and 170 patients received 4% ophthalmic sodium cromoglycate twice daily, together with placebo eye-drops twice daily, for the treatment of seasonal allergic conjunctivitis (SAC) to birch pollen. The treatment period was 4 weeks during the birch pollen season. Daily pollen counts were used to identify the peak 14-d period. Clinical examinations were made before the start of treatment, after 1 week of treatment, and at the end of the treatment period. Patients kept daily diary record cards of eye symptom severity and concomitant therapy. Symptoms were generally mild and, except for chemosis (week 4) and soreness (weeks 2 and 3), which were less in the 4% group (P < or = 0.05), no significant treatment differences were seen for symptoms or for antihistamine rescue therapy. Both treatments were considered to be very or moderately effective by more than 90% of patients, and no treatment differences occurred in either clinicians' or patients' opinions of efficacy. The results indicate that the use of 4% sodium cromoglycate eye-drops twice daily is as effective and well tolerated as 2% sodium cromoglycate four times daily in the treatment of birch-pollen conjunctivitis.