Comparison of efficacy and safety of topical Ketotifen (Zaditen) with Cromolyn sodium in the treatment of Vernal keratoconjunctivitis

Background: 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).
 Methods: 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 photophobia were scored on a 4-points severity scale.
 Results: 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.
 Conclusion: 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.
 Keywords : VKC , allergic conjuctivitis , zadite