Comparison of efficacy and safety of topical Ketotifen [Zaditen] with cromolyn sodium in the treatment of vernal keratoconjunctivitis

ABSTRACT

This study compared the efficacy of Ketotifen fumarate.025% [Zaditen] with Cromolyn sodium 4% [Opticrom] eye drops in prevention of itching, tearing, and redness in Vernal Keratoconjunctivitis [VKC]. This double blind randomized single center clinical trial conducted between April and August 2004 in Yazd. One hundred eligible patients with clinical diagnosis of moderate VKC were randomly prescribed Zaditen [group A n=50] and Cromolyn sodium [group B n=50] eye drops for a 4 weeks period. Itching, lacrimation, redness, and hotophobia were scored on a 4-points severity scale. After 7 days of treatment, the response rates based on subjects assessment of global efficacy was significantly greater in Ketotifen group [61.5%] than in Cromolyn group[53%].A clear response to treatment occurred in 94.4 of Zaditen and 81.2% of Sodium Cromoglycate treated patients. The investigator,s assessment of response rates also showed that Ketotifen was superior to Cromolyn sodium [P=0.001]. Ketotifen produced a significantly better outcome than Cromolyn for relief of signs and symptoms of VKC [P<0.05]. Ketotifen fumarate treatment significantly reduced the total signs and symptoms score for each patients, in compare with day 0. Ketotifen had a faster onset of action and provided better symptom relief than Cromolyn. The rapid onset of action and symptom control, make Zaditen a valuable treatment for VKC