NEDOCROMIL SODIUM 2-PERCENT EYE DROPS FOR TWICE-DAILY TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS - A SWEDISH MULTICENTER PLACEBO-CONTROLLED STUDY IN CHILDREN ALLERGIC TO BIRCH POLLEN
C. Moller et al., NEDOCROMIL SODIUM 2-PERCENT EYE DROPS FOR TWICE-DAILY TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS - A SWEDISH MULTICENTER PLACEBO-CONTROLLED STUDY IN CHILDREN ALLERGIC TO BIRCH POLLEN, Clinical and experimental allergy, 24(9), 1994, pp. 884-887
This was a multicentre, double-blind, randomized group comparative stu
dy in which 77 children, aged 6-16 years, received 2% nedocromil sodiu
m eye drops and 72 received placebo, one drop into each eye twice dail
y. The treatment period was 4 weeks, covering the peak birch pollen se
ason. Prior to the start of the season, patients who had attended the
clinic the previous 2 years because of seasonal allergic conjunctiviti
s (SAC) to birch pollen, entered a one week baseline period during whi
ch symptoms were assessed, diary cards completed, and routine sampling
of blood and urine carried out. The double-blind treatment period the
n commenced at the onset of the birch pollen season. Patients/parents
kept daily diary record cards of eye symptom severity and concomitant
therapy. Conjunctivitis was mild in both treatment groups but nedocrom
il sodium was more effective than placebo in controlling symptoms. Dur
ing the 2-3 weeks of peak pollen counts, this therapeutic effect was s
tatistically significant for itching (P < 0.01), watering (P < 0.05) a
nd total symptom score (P < 0.01), but was not significant for grittin
ess (P = 0.08) or redness (P = 0.06). Global opinions of efficacy show
ed no difference between treatments, due to a high placebo effect (how
ever, the diary card data indicated a significant improvement with ned
ocromil sodium). We therefore conclude that nedocromil sodium 2% eye d
rops, administered twice daily, is an effective treatment for SAC in c
hildren.