Prospective, Randomised, Double-Masked Comparison of 0.1% Tacrolimus Ointment and 0.2% Olopatadine Eye Drops in the Treatment of Refractory Allergic Conjunctivitis

Abstract

\n Purpose- To analyse and compare the outcomes of topical tacrolimus 0.1% and 0.2 % olopatadine eye drops in refractory allergic conjunctivitis.Methods-Prospective, double masked, randomized control trial conducted from January to December 2015 at a tertiary eye care centre with a follow up of 3 months. A total of 100 patients were enrolled. Fifty patients were allocated into the tacrolimus group (Group A) and olopatadine group (Group B) each. Detailed demographics, systemic history, uncorrected, best corrected visual acuity, intraocular pressure (IOP), anterior and posterior segment findings were recorded. Subjective symptoms and objective signs were recorded in the data forms at baseline and 1, 4, 8 & 12 weeks. The score of the worse eye was considered for analysis. On follow up, vision, IOP, side effects, objective signs and symptoms were recorded.Results- Out of 100 patients, 4 were lost to follow up. The mean age in Group A was 18.63 ± 7.89 years and Group B was 17.21 ± 9.17 years. The M:F ratio was 1.5:1. Among 96 patients, 6 (6.66%) had allergic rhinitis and 3 (3.33%) were asthmatic. The mean sign score, symptom score, giant papillae score, palpebral conjunctival hyperaemia and bulbar conjunctival hyperaemia score was statistically significant between two groups. In Group A, 22.9% patients had punctate epithelial erosions while none had in Group B at 1 month follow up.Conclusion- Topical tacrolimus 0.1% is safe and effective with minimal side effects. It should be considered for patients refractory to conventional treatment or requiring long term treatment, to avoid steroid related complications.