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 in reducing the ocular signs and symp toms accompanying contact lens-associated giant papillary conjunctivitis. METHODS: In a randomized, double-masked, placebo-controlled, parallel group study conducted at 14 academic or private practice clinics, 223 adults with contact lens-associated giant papillary conjunctivitis received either loteprednol or the loteprednol vehicle (placebo), one drop, four times daily for 6 weeks. Papillae, itching, contact lens intolerance, other signs and symptoms of giant papillary conjunctivitis (0-to-3 or 0-to-4 grade scales), and intraocular pressure were measured. RESULTS: The proportion of patients treated with loteprednol who at final visit demonstrated an improvement in papillae of at least one grade (78%, 85/109) was significantly greater than the proportion of those treated with placebo (51%, 56/110; P = .001). A treatment difference favoring loteprednol was seen with improvement in itching (95% vs 81%, 104/109 vs 89/110; P < .001) and lens intolerance (87% vs 77%, 95/109 vs 85/110; P = .053). Eight of 109 patients (7%, all taking loteprednol) had an intraocular pressure increase of 10 mm Hg or more on at least one visit during treatment. After discontinuation of loteprednol, intraocular pressure returned to normal levels. Both treatments were well tolerated, and no serious unexpected treatment-related medical events were reported. CONCLUSIONS: The rapid therapeutic response combined with the low incidence and transient nature of any intraocular pressure increase suggests that loteprednol is an appropriate treatment for giant papillary conjunctivitis.