Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis. Loteprednol Etabonate US Uveitis Study Group.

PURPOSE

To compare the safety and efficacy of loteprednol etabonate 0.5% ophthalmic suspension with prednisolone acetate 1.0% ophthalmic suspension in reducing the ocular signs and symptoms associated with acute anterior uveitis.

METHODS

Two prospective studies were conducted in sequence. Both were parallel, randomized, double-masked, active-controlled comparisons conducted at academic or private practice clinics in the United States. Efficacy was evaluated by the proportion of patients with a score of 0 for key signs and symptoms of uveitis. Intraocular pressure was increased regularly. The first study involved up to 42 days of treatment, starting with a dose of eight times per day. The second study involved up to 28 days of treatment, starting 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 etabonate, 88% prednisolone acetate, P = .194) and flare (71% loteprednol etabonate, 81% prednisolone acetate, P = .330). In the second study (N = 175), the proportion of patients achieving resolution by the final visit was anterior 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 Hg 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 symptoms was noted in both treatment groups, loteprednol etabonate was less effective than prednisolone acetate in both of these controlled studies. However, the more favorable profile of loteprednol etabonate with respect to intraocular pressure increase may make it useful in many patients.