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Edward J Meier,1 Gail L Torkildsen,2 Paul J Gomes,3 Mark C Jasek4 1Apex Eye, Mason, OH, USA; 2Andover Eye, Andover, MA, USA; 3Allergy, Ora, Inc., Andover, MA, USA; 4Eyevance Pharmaceuticals, TX, USA Purpose: The purpose of these Phase III studies was to evaluate the efficacy and safety of cetirizine ophthalmic solution 0.24% compared with vehicle in the treatment of allergen-induced conjunctivitis using the Ora conjunctival allergen challenge (CAC)® model.Methods: The single-center (Study 1) and multi-center (Study 2), double-masked, randomized, vehicle-controlled, parallel group, CAC studies were conducted over ~5 weeks and four study visits. The study design only differed in entry criteria: Study 2 required more severe allergic conjunctivitis symptoms. Subjects were screened for an allergen response at Visits 1 and 2 and then randomized at Visit 3. Approximately 100 subjects were randomized in each study. The primary efficacy endpoints were ocular itching and conjunctival redness 15 minutes and 8 hours post-treatment, post-CAC.Results: Cetirizine treatment administered 15 minutes or 8 hours prior to CAC resulted in significantly lower ocular itching at all time points post-CAC (P |
