Controlled evaluation of loteprednol etabonate and prednisolone acetate inthe treatment of acute anterior uveitis

PURPOSE: To compare the safety and efficacy of loteprednol etabonate 0.5% o phthalmic suspension with prednisolone acetate 1.0% ophthalmic suspension i n reducing the ocular signs and symptoms associated with acute anterior uve itis, METHODS: Two prospective studies were conducted in sequence. Both were para llel, randomized, double-masked, active-controlled comparisons conducted at academic or private practice clinics in the United States. Efficacy was ev aluated by the proportion of patients with a score of 0 for key signs and s ymptoms of uveitis, Intraocular pressure was increased regularly. The first study involved up to 42 days of treatment, starting with a dose of eight t imes per day. The second study involved up to 28 days of treatment, startin g with a dose of 16 times per day. RESULTS: In the first study (N = 70), the proportion of patients achieving resolution by the final visit was anterior chamber cell (74% loteprednol et abonate, 88% prednisolone acetate, P = .194) and flare (71% loteprednol eta bonate, 81% prednisolone acetate, P = .330), In the second study (N = 175), the proportion of patients achieving resolution by the final visit was ant erior chamber cell (72% loteprednol etabonate, 87% prednisolone acetate, P = .015) and flare (66% loteprednol etabonate, 82% prednisolone acetate, P = .017). In both studies, intraocular pressure increase of more than 10 mm H g was observed more frequently in patients receiving prednisolone acetate ( seven patients) than those receiving loteprednol etabonate (one patient). CONCLUSIONS: Although a clinically meaningful reduction of signs and sympto ms was noted in both treatment groups, loteprednol etabonate was less effec tive than prednisolone acetate in both of these controlled studies, However , the more favorable profile of lotepred nol etabonate with respect to intr aocular pressure in crease may make it useful in many patients. (C) 1999 by Elsevier Science Inc. All rights reserved.