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RM Schiffman, MB Abelson, HJ Crampton, AP Slugg, C Michaelson, RR Bradford, B Kim, JC Lue, SM Whitcup; Efficacy and Safety of Ophthalmic Epinastine Evaluated Using the Conjunctival Antigen Challenge Model in Patients with a History of Allergic Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2002;43(13):107.
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Purpose:Epinastine hydrochloride is a new generation histamine H1-receptor antagonist with mast cell stabilizing activity. We evaluated the safety and efficacy of epinastine using the validated, standardized conjunctival antigen challenge (CAC) model in patients with allergic conjunctivitis (AC). Methods:Eligible patients for this single-center, double-masked, vehicle-controlled phase 3 clinical trial had a history of AC but no active signs or symptoms, and a positive CAC reaction at the initial screening on day 0 and at the confirmation visit on day 7. Each eye received 1 drop of study medication 15 minutes before antigen challenge on day 21 and 8 hours before antigen challenge on day 35. The interventions were: epinastine HCl 0.05% ophthalmic solution in both eyes (epi/epi), vehicle in both eyes (veh/veh), or epinastine in one eye and vehicle in the other (epi/veh). Ocular signs and symptoms were recorded at 3 to 5, 5 to 10, and 10 to 20 minutes post-challenge. Results:Mean age of patients (n=126) was 38.4 years (range 11 to 67 years). In a paired-eye analysis (n=67 epi/veh), epinastine significantly reduced the severity of the primary efficacy variables ocular itching and conjunctival hyperemia versus vehicle at all timepoints (P < .001). Epinastine reduced the severity of ciliary and episcleral hyperemia, chemosis, and lid swelling versus vehicle at all timepoints (P ≤ .009). There were no ocular adverse events nor any treatment-related adverse events. Conclusion:Epinastine significantly reduced the signs and symptoms of AC, had a rapid onset of action, a duration of at least 8 hours, and was well-tolerated in all patients.
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