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Lan Gong, Xinhuai Sun, Lipika Roy, Byron Zhu, Albert Elion-Mboussa, Esther Chu; Loteprednol Etabonate Ophthalmic Suspension, 0.2% Versus Olopatadine Hydrochloride Ophthalmic Solution, 0.1% In The Treatment of Seasonal Allergic Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2012;53(14):4013.
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Treatment options for seasonal allergic conjunctivitis (SAC) include corticosteroids, antihistamines, and mast cell stabilizers. The objective of this study was to compare the safety and efficacy of loteprednol etabonate ophthalmic suspension, 0.2% (LE, Alrex®) with that of olopatadine hydrochloride ophthalmic solution, 0.1% (olopatadine, Patanol®)
2-week, randomized, double-masked study. Chinese patients with acute SAC experiencing severe ocular itching (Grade 4) and bulbar conjunctival injection ≥Grade 2 received 1 drop of LE QID at 4 h intervals or olopatadine BID at 6-8 h intervals for 15 days. Primary efficacy endpoints included change from baseline (CFB) in ocular itching and bulbar conjunctival injection at Day 15. Safety outcomes included adverse events (AEs), visual acuity, biomicroscopy findings and intraocular pressure (IOP).
Three hundred subjects were randomized to treatment (n=151 LE, n=149 olopatadine). Baseline ocular itching and bulbar conjunctival injection were similar between treatments. The mean (SD) CFB at Day 15 in the LE and olopatadine treatment groups, respectively, were -3.74 (0.47) and -3.28 (0.91) for ocular itching and -1.91 (0.52) and -1.71 (0.59) for bulbar conjunctival injection and were significantly greater with LE compared with olopatadine for both endpoints (P≤0.0006). The proportion of subjects with complete resolution of ocular itching (74.6% vs. 50.7%, respectively) and bulbar conjunctival injection (78.3% vs. 61.3%, respectively) was also significantly greater with LE compared to olopatadine (P≤0.0027). AEs were few and similar between treatment groups. There was no difference between treatment groups in the proportion of subjects experiencing an IOP increase ≥5 mm Hg from baseline (6.0% [9/151] vs. 2.7% [4/149,], respectively, P=0.2563), and no patient reported a clinically significant increase in IOP (≥10 mm Hg).
LE was statistically better than olopatadine in the relief of ocular itching and bulbar conjunctival injection at Day 15 with comparable effects on IOP in Chinese patients.
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