Clinical study to evaluate safety and efficacy of tacrolimus 0.1% eye ointment in treatment of vernal keratoconjunctivitis

Introduction: Vernal keratoconjunctivitis is a seasonally recurring, chronic, allergic bilateral inflammatory disorder of the conjunctiva and cornea caused due to immune mediated hypersensitivity reaction. Tacrolimus is an immunomodulator which induces suppression of T lymphocytes activity and causes reduction of ocular inflammation. Hence, in our present study we aim to evaluate the efficacy of 0.1% tacrolimus eye ointment as first line therapy in the management of Vernal Keratoconjunctivitis. Materials and Methods: This was a clinical, prospective and interventional study including 100 eyes of 50 patients with VKC which were serially selected. 0.1% tacrolimus eye ointment was instilled twice daily over a period of 12 weeks. On every fortnightly follow up, patients were assessed for 5 symptoms and 4 signs and the severity was graded as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe)in order to evaluate the efficacy of the drug. Results: There were 50 patients with VKC comprising of 41 males and 09 females. After treatment with Tacrolimus 0.1% eye ointment, there was statistically significant improvement in symptoms of VKC including itching, redness, photosensitivity, foreign body sensation and mucus discharge (P<0.001). Significant improvement in clinical signs of VKC including conjunctival hyperaemia, papillary hypertrophy, giant papillary conjunctivitis and limbal involvement (P<0.001) was seen at the end of the study. No significant adverse effects of tacrolimus were seen in these patients. Conclusion: Topical 0.1% tacrolimus eye ointment is very effective in the treatment of Vernal Keratoconjunctivitis with minimal long term side effects.