Combination Therapy of 0.1% Fluorometholone and 0.05% Azelastine in Eyes with Severe Allergic Conjunctival Diseases: A Randomized Controlled Trial

Abstract

This study sought to evaluate the efficacy of the isolated use of fluorometholone compared with the combined use of azelastine and fluorometholone for the treatment of severe allergic conjunctival disease (ACD). One hundred and eleven patients with severe ACD were randomized into two groups: one treated with topical 0.1% fluorometholone combined with 0.05% azelastine and the other with 0.1% fluorometholone alone. The Ocular Surface Disease Index (OSDI) and the signs of keratopathy, palpebral conjunctiva papillae and conjunctival congestion were scored before and at one, two and six weeks after treatment and compared between the groups. The intra-ocular pressure (IOP) was also monitored. There were no significant differences between the groups in the baseline mean scores of signs and OSDI scores, which gradually improved at all visits after therapy in both groups. Although the time effect was significant for all the parameters (all p < 0.001), the reduction in corneal involvement scores from week 2 to week 6 was insignificant in both groups (p = 0.460 for the steroids group and p = 0.074 for the combination group). All signs and symptoms were significantly more improved in the combination group than in the isolated group at each control visit. IOP remained stable at all visits (all p < 0.001), except one patient in each group had elevated IOP over 21 mmHg. While both the isolated use of fluorometholone and combined use of azelastine and fluorometholone are effective in alleviating the signs and symptoms of severe ACD, optimal response can be achieved with adjunctive treatment including azelastine.