SAFETY AND EFFICACY OF LOTEPREDNOL ETABONATE FOR TREATMENT OF PAPILLAE IN CONTACT LENS-ASSOCIATED GIANT PAPILLARY CONJUNCTIVITIS

Loteprednol etabonate (LE) is a new corticosteroid based on the ''soft drug'' concept. Contact lens-associated giant papillary conjunctiviti s (GPC) was studied as a model for the anti-inflammatory effect of LE. Patients with bilateral GPC were enrolled in a multicenter, randomize d, double-masked, placebo-controlled, parallel group comparison of lot eprednol etabonate 0.5% ophthalmic suspension and the LE vehicle (plac ebo). Patients were instructed to instill 1 drop of the test medicatio n into each eye 4 times daily for 4 weeks, and follow-up examinations occurred on Days 2 or 3, 7, 14, 21, and 28 of masked therapy. Of 113 p atients enrolled, 110 patients (LE=55; placebo=55) completed the study as planned. Patients receiving LE demonstrated significant reduction in the primary ocular signs of GPC (papillae, p<0.001) and were rated better in the Investigator's Global Assessment (p=0.017). LE did not e levate intraocular pressure during the study, and ratings for bulbar c onjunctival injection and the Patient Opinion Assessment demonstrated statistical trends that favored treatment with LE. LE was well tolerat ed and was clinically effective for the treatment of GPC.