Comparison of the efficacy and tolerability of topically administered azelastine, sodium cromoglycate and placebo in the treatment of seasonal allergic conjunctivitis and rhino-conjunctivitis

• Published in: Current medical research and opinion 2003, Vol.19 (4), p.313-320
• Main Authors: James, I.G.V., Campbell, L. M., Harrison, J. M., Fell, P.J., Ellers-Lenz, B., Petzold, U.
• Format: Article
• Language: English
• Subjects: Administration, Topical; Adolescent; Adult; Aged; Allergic rhino-conjunctivitis; Anti-Allergic Agents - therapeutic use; Anti-Asthmatic Agents - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Antiallergic drugs; Azelastine; Biological and medical sciences; Conjunctivitis, Allergic - drug therapy; Conjunctivitis, Allergic - physiopathology; Cromolyn Sodium - therapeutic use; Double-Blind Method; Female; H1-antagonists; Histamine H1 Antagonists - therapeutic use; Humans; Male; Medical sciences; Middle Aged; Ophthalmic Solutions - therapeutic use; Phthalazines - therapeutic use; Rhinitis, Allergic, Seasonal - drug therapy; Rhinitis, Allergic, Seasonal - physiopathology; Sodium cromoglycate; Topical antihistamines
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079903125001785

SUMMARY Objective and setting: Azelastine (AZE) in a novel, eye drop, formulation, was compared with topically applied sodium cromoglycate (SCG) and placebo (PLA) in the treatment of seasonal allergic conjunctivitis or rhino-conjunctivitis in a multicentre, parallel group study. Research design: 144 subjects ranging in age from 16 to 65 years participated. All had at least a 2-year history of seasonal allergic conjunctivitis and were symptomatic at the time of inclusion. Medications were administered topically either twice daily (AZE/PLA) or four times daily (SCG) over a 2-week treatment period. Method and outcome measures: Azelastine and placebo were compared double-blind; the comparison versus SCG was carried out in an open manner. Itching, redness, flow of tears, eyelid swelling, foreign-body sensation, photophobia, soreness and discharge were scored on a 4-point severity scale. Results: Results for the decrease of main conjunctivitis symptoms (itching, tearing and conjunctival redness) showed a marked effect for both active treatments on day 3 with a sustained improvement on days 7 and 14. A clear response to treatment (an improvement of sum scores for day 3 of >3 points compared to baseline) occurred in 85.4% of azelastine-treated patients, 83.0% of sodium cromoglycate patients and 56.3% of placebo patients. Response rates for both active treatments were statistically superior to those for placebo (azelastine p = 0.005; sodium cromoglycate p = 0.007). Global assessment of efficacy was at least 'satisfactory' for 90.0% of azelastine patients, 81.3% of sodium cromoglycate patients and 66.3% of placebo-treated patients. The most frequent adverse effects were transient application site reactions which tended to disappear with increasing duration of treatment, and, less frequently, taste perversion. Conclusion: The results of this study indicate that the therapeutic use of azelastine eye drops in patients with seasonal allergic conjunctivitis or rhino-conjunctivitis can be recommended.