Azelastine eye-drops in seasonal allergic conjunctivitis or rhinoconjunctivitis. A double-blind, randomized, placebo-controlled study.
This study was carried out to assess the efficacy of 0.025% and 0.05% azelastine eye-drops in patients with seasonal allergic conjunctivitis of > or = 1 year's duration. A total of 151 patients received 0.025% or 0.05% azelastine eye-drops or placebo b.i.d. for 14 days according to a double-blind, randomized, placebo-controlled, parallel-dosing design; 129 patients completed the study as planned. The three target symptoms, scored on 4-point scales, were itching, lacrimation, and redness of the eyes; responders were patients whose symptom sum score decreased by > or = 3 from a baseline score of > or = 6 by day 3. Mean scores of these and five other symptoms were recorded also on days 7 and 14, and patients kept daily diaries of the three main symptoms and swollen eyelids. Responder rates were 73% for 0.025% (P=0.115 vs placebo) and 82% for 0.05% azelastine eye-drops (P=0.011 vs placebo) and 56% for placebo. The time courses of the mean (investigators' and patients') scores for the three main symptoms reflected the dose-dependent effect of azelastine eye-drops. One patient each from the two azelastine groups and three from the placebo group withdrew because of inefficacy. Adverse drug reactions were reported by 14 and 24 patients receiving 0.025% and 0.05% azelastine eye-drops, respectively, and by eight placebo patients. These reactions were mainly slight application site reactions and taste perversion (bitter or unpleasant taste). Azelastine eye-drops are effective and well tolerated at a dose of 0.05% for the treatment of seasonal allergic conjunctivitis.
Giede-Tuch
C
C
Westhoff
M
M
Zarth
A
A
D000293:Adolescent; D000328:Adult; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D010793:Phthalazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012449:Safety; D016896:Treatment Outcome
D006634:Histamine H1 Antagonists; D009883:Ophthalmic Solutions; D010793:Phthalazines; C020976:azelastine