A double-masked, placebo-controlled evaluation of the efficacy and safety of loteprednol etabonate in the treatment of giant papillary conjunctivitis.

PURPOSE: To evaluate the safety and effectiveness of loteprednol etabonate 0.5% ophthalmic suspension (LE) for reducing the ocular signs and symptoms accompanying contact lens associated giant papillary conjunctivitis (GPC). We conducted a randomized, double-masked, placebo-controlled, parallel study at 11 U.S. academic or private practice clinics.

METHODS: Two hundred and twenty adults with contact lens associated GPC were enrolled in this study. Patient were treated with either LE or the loteprednol etabonate vehicle (placebo), q.i.d. for 6 weeks. Papillae, itching, lens intolerance, as well as other signs and symptoms of GPC (0 to 3 or 0 to 4 point severity scales), and intraocular pressure were measured.

RESULTS: The proportion of patients treated with LE demonstrating an improvement in papillae of at least one grade (75%) was significantly greater than the proportion of those treated with placebo (50%, P < 0.001). A treatment difference favoring LE was also seen with improvement in itching (92% vs. 76%, P = 0.001) and lens intolerance (84% vs. 66%, P = 0.002). Three patients (all on LE) had an intraocular pressure (IOP) elevation of 10 mm Hg or higher from baseline on at least one on-treatment visit. Cessation of therapy was required in one of these patients.

CONCLUSIONS: Both treatments were well tolerated and no serious, unexpected, treatment-related medical events were reported. The rapid therapeutic response, combined with the low incidence, late development, and transient nature of any IOP elevation suggests that LE may be helpful in treating GPC.