Comparison of Topical Mitomycin C and 5 Fluorouracil as Primary Treatment modalities for Ocular Surface Squamous Neoplasia: A Randomized Controlled Trial Study

The primary objective of the study is to compare the efficacy and safety of topical mitomycin c and topical 5 fluorouracil as primary treatment modalities for ocular surface squamous neoplasia(OSSN). OSSN is a spectrum  neoplastic pathology ranging from benign to malignant neoplasia arising from the conjunctiva of the eye. Gold standard of treatment includes excision of the tumor with/without double freeze cryotherapy. Recent advances in the treatment involves the use of topical chemotherapeutic agents such as topical interferon alpha2B, mitomycin c 5 fluorouracil as non invasive alternatives for primary therapy. The most popularly used chemotherapy agent is topical interferon alpha2B which has its own drawbacks in terms of limited availability, long duration of therapy with high cost for therapy and need for maintaining a cold chain to ensure efficacy of drug. Although several studies have been done comparing the different chemotherapy agents in as primary therapy in OSSN , however most of the studies done are retrospective in nature with limited literature available comparing topical mitomycin c and topical 5 fluorouracil directly with each other in a head to head comparison in same setting in a randomized manner. Our study aims to provide direct head to head comparison for the effectiveness and safety profile of topical mitomycin c and topical 5 fluorouracil in a randomized controlled study thereby eliminating any pre existing bias in an attempt to create sufficient data to justify use of these as safe , effective , easily available and cost effective treatment alternatives specially in Indian setting.