Objectives: This post hoc analysis used data from a previous study to more precisely evaluate the efficacy of olopatadine hydrochloride and epinastine hydrochloride in alleviating various levels of severity of ocular itching and conjunctival redness and to determine whether there were any significant differences in the number of responders to treatment.
Methods: The original study was a randomized, double-masked allergen challenge comparison assessment. Adult patients with allergic conjunctivitis were screened (visits 1 and 2); those who exhibited positive allergic reactions at both visits were randomized to 1 of 3 groups. olopatadine/epinastine, olopatadine/placebo, or epinastine/placebo. At visit 3, each eye was treated with study medication, and then challenged with allergen. Itching, redness, and chemosis assessments were recorded. For the present post hoc analysis, each eye in the olopatadine/epinastine group was separately classified at each time point, based on the pretreatment severity of their symptom (itching) and sign (conjunctival redness) scores, as moderate, moderate/severe, or severe. Data were analyzed to determine responders (eyes with itching and/or conjunctival redness scores of 0 [none]).
Results: Of 96 patients screened, 66 were randomized to treatment (36 women, 30 men; mean age, 44.38 years [range, 20-71 years]). Olopatadine-treated eyes exhibited lower mean itching scores than epinastine-treated eyes in the moderate/severe and severe groups at all 3 time points (3, 5, and 7 minutes), with significance in the moderate/severe group at 5 minutes (P = 0.05) and in the severe group at 5 and 7 minutes (P = 0.017 and P = 0.02, respectively). Olopatadine-treated eyes had mean conjunctival redness scores similar to epinastine-treated eyes in all severity groups at all time points (10, 15, and 20 minutes) except in the severe group at 10 minutes (P = 0.03). On response analysis, for itching, the proportion of responders was significantly greater in the olopatadine group versus the epinastine group 7 minutes after challenge (27 [50.9%] vs 14 [26.4%]; P = 0.016). For conjunctival redness, the proportion of responders was significantly greater with olopatadine treatment versus epinastine treatment at 15 and 20 minutes after challenge (15 minutes, 12 [22.6%] vs 1 [1.9%] [P = 0.002]; 20 minutes, 10 [18.9%] vs 1 [1.9%] [P = 0.008]).