M Daniell1, M Constantinou, H T Vu, H R Taylor. 1. Centre for Eye Research Australia, University of Melbourne, Corneal Clinic, Royal Victorian Eye and Ear Hospital, Locked Bag 8, East Melbourne 8002, Australia. daniellm@ozemail.com.au
Abstract
AIM: To evaluate the efficacy, safety, and therapeutic effect of topical ciclosporin A 0.05% as a steroid sparing agent in steroid dependent allergic conjunctivitis. METHODS: Prospective, randomised, double masked, placebo controlled trial comparing signs, symptoms, and the ability to reduce or stop concurrent steroid in steroid dependent atopic keratoconjunctivitis and vernal keratoconjunctivitis using 0.05% topical ciclosporin A compared to placebo. Steroid drop usage per week (drug score), symptoms, and clinical signs scores were the main outcome measures. RESULTS: The study included an enrolment of 40 patients, 18 with atopic keratoconjunctivitis and 22 with vernal keratoconjunctivitis. There was no statistical significant difference in drug score, symptoms, or clinical signs scores between the placebo and ciclosporin group at the end of the treatment period. No adverse reactions to any of the study formulations were encountered. CONCLUSIONS:Topical ciclosporin A 0.05% was not shown to be of any benefit over placebo as a steroid sparing agent in steroid dependent allergic eye disease.
RCT Entities:
AIM: To evaluate the efficacy, safety, and therapeutic effect of topical ciclosporin A 0.05% as a steroid sparing agent in steroid dependent allergic conjunctivitis. METHODS: Prospective, randomised, double masked, placebo controlled trial comparing signs, symptoms, and the ability to reduce or stop concurrent steroid in steroid dependent atopic keratoconjunctivitis and vernal keratoconjunctivitis using 0.05% topical ciclosporin A compared to placebo. Steroid drop usage per week (drug score), symptoms, and clinical signs scores were the main outcome measures. RESULTS: The study included an enrolment of 40 patients, 18 with atopic keratoconjunctivitis and 22 with vernal keratoconjunctivitis. There was no statistical significant difference in drug score, symptoms, or clinical signs scores between the placebo and ciclosporin group at the end of the treatment period. No adverse reactions to any of the study formulations were encountered. CONCLUSIONS: Topical ciclosporin A 0.05% was not shown to be of any benefit over placebo as a steroid sparing agent in steroid dependent allergic eye disease.
Authors: Esen Karamursel Akpek; John K Dart; Stephanie Watson; William Christen; Dilek Dursun; Sonia Yoo; Terrence P O'Brien; Oliver D Schein; John D Gottsch Journal: Ophthalmology Date: 2004-03 Impact factor: 12.079
Authors: Soyang Ella Kim; Victoria Nowak; Ana Quartilho; Frank Larkin; Melanie Hingorani; Stephen Tuft; Annegret Dahlmann-Noor Journal: Cochrane Database Syst Rev Date: 2020-10-21