Comparison of efficacy and safety of topical ketotifen [zaditen] and cromolyn sodium in vernal keratoconjunctivitis

ABSTRACT

The purpose of this study is to compare the efficacy of Ketotifen fumarate 0.025% [Zaditen] with Cromolyn sodium 4% eye drops in prevention of itching, tearing and redness in vernal keratoconjunctivitis [VKC]. This double masked 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 assigned to Zaditen [Group A, n=50] and Cromolyn sodium [Group B, n=50] eye drops for a 4 week period. Itching, lacrimation, redness and photophobia were scored on a 4-point severity scale. At the follow up visits, the responder rate based on subjects assessment of global efficacy was significantly greater in Ketotifen group [71.5%] than in Cromolyn group [53%]. A clear response to treatment occurred in 94.4% of Zaditen patients and 81.2% of sodium Cromoglycate patients. The investigator's assessment of responder rates also showed that Ketotifen was superior to Cromolyn sodium [p=0.001]. Ketotifen produced a significantly better outcome than Cromolyn [p<0.05] for relief of signs and symptoms of VKC. Ketotifen fumarate treatment significantly reduced the total signs and symptoms score for each patient compared to 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