Controlled comparison of two fluorometholone formulations in the antigen challenge model of allergic conjunctivitis

We compared the safety and efficacy of MethaSite, a gel-forming suspension (0.1% fluorometholone), to a commercially available 0.1% fluorometholone ointment, FML S.O.P., using an antigen challenge model. Subjects with known allergic histories were exposed to increasing concentrations of cat dander, ragweed, or grass at visits 1 and 2. Allergic responses of conjunctival injection, chemosis, and subjective itching were quantified on a scale from zero to 3; the sum of these ratings constituted the total allergic score. At visit 3, 105 subjects with total scores of > or = 5 received a drop of MethaSite in one eye and a 0.5 inch ribbon of FML ointment in the other eye. Three and 6 hours postdose, the eyes were challenged with the antigen concentration that provoked significant allergic response at visit 2. We determined safety by evaluating changes in visual acuity, intraocular pressure, and biomicroscopy that occurred between visits 1 and 3. Eyes treated with MethaSite and FML responded similarly to the antigen challenges. Both groups demonstrated suppression of allergic response 3 and 6 hours postdose through equivalent and significant reductions in total allergy scores and individual ratings of injection, chemosis, and itching. In this population, MethaSite was equivalent to FML ointment in safety and efficacy.