A Comparative Study of Efficacy and Safety of Topical Loteprednol Etabonate 0.5% and Cyclosporin A 0.05% for the Treatment of Vernal Keratoconjunctivitis
Author(s): Sharika Ganjoo, Sachit Mahajan*, Sanjay Kai and Satish Kumar Gupta
Background: Vernal keratoconjunctivitis (VKC) is a recurrent, bilateral, interstitial, allergic seasonal conjunctivitis. Topical steroids are one of the most effective drugs for management of signs and symptoms of VKC. Cysclosporin is a calcineurin inhibitor that abolishes T cell proliferation, decreasing histamine release from mast cells and basophils. This study was conceptualized to evaluate the safety and efficacy of loteprednol etabonate 0.5% and cyclosprin-A 0.05% to generate evidence for managing VKC more effectively.
Material and methods: This non blinded comparative study included 200 patients with mild to moderate VKC who were randomized to two groups A and B. Group A received topical loteprednol etabonate 0.5% four times a day and group B received topical cyclosporin-A 0.05% two times a day. Five symptoms and four signs were evaluated on day 0 and second, fourth and 12th week after starting treatment. Data was analyzed by using student t-test. p value <0.05 was considered significant.
Results: The mean age in this study was 11.18 ± 4.9 years with 75% males and 25% females. The mean grade scores were lower for loteprednol 0.5% group than cyclosporin-A 0.05% with regards to symptoms and blepharitis, conjunctival congestion, and papillae. In, punctate keratopathy group, mean grade scores were lower in cyclosporin-A 0.05% group. No significant adverse effects were noted with both the drugs over 12 weeks.
Conclusions: Both the drugs were equally safe but loteprednol etabonate 0.5% was more efficacious as well as cost effective than cyclosporin-A 0.05% in relieving symptoms and signs of vernal keratoconjunctivitis.