A randomized, double masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis

Objective: To evaluate the effects of loteprednol etabonate (LE) 0.2% in re ducing the signs and symptoms of seasonal allergic conjunctivitis. Design: Randomized, double-masked, placebo-controlled, parallel group multi center study of 6 weeks duration. Participants: A total of 135 patients with signs and symptoms of seasonal a llergic conjunctivitis participated. Intervention: All patients received either LE 0.2% or placebo (vehicle) fou r times a day in both eyes for 42 days. Main Outcome Measures: Bulbar conjunctival injection (primary sign) and itc hing (primary symptom) over the first 2 weeks of treatment was measured. Results: A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0-3 scale) and itchi ng (3.4 vs. 3.0 units on a 0-4 scale) over the first 2 weeks. The treatment effect by these measures was -0.5 and -0.4 units in favor of LE (P less th an or equal to 0.008), Resolution (i.e., the proportion of patients with si gns or symptoms no longer present) at day 14 strongly favored LE-treated pa tients (36% and 15%; 58% and 38%, for injection and itching, respectively). Both treatments were well tolerated. One patient in each treatment group ( 1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment. Conclusions: Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0. 2% had a safety profile comparable to placebo.