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M.H. Friedlaender, L. Sharf, D. Breshears; Control of Ocular Allergy Symptoms by Epinastine HCl 0.05% in a Conjunctival Antigen Challenge Evaluation . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4841.
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Purpose: Efficacy evaluation of epinastine HCl 0.05%, a new topical ophthalmic antihistamine with mast cell–stabilizing and anti–inflammatory properties, using the conjunctival antigen challenge (CAC) model. Methods: This was a single–center, randomized, investigator–masked, vehicle–controlled study. Participants (N=24) were female, 18–75 years old, and had a history of allergic conjunctivitis. On day 0, the amount of antigen that elicited itching and hyperemia scores of 2 or greater (on a scale of 0–4) was established as the threshold dose. On day 7, each patient was assigned to receive 1 drop of epinastine HCl 0.05% ophthalmic solution in one eye and vehicle in the other eye in randomized fashion, 5 minutes prior to CAC (onset of efficacy assessment). On day 14, study drug was instilled 12 hours prior to CAC (duration of efficacy assessment). Results: Patients’ mean age was 43.0 years (range 23–60). In the onset of efficacy assessment, eyes treated with epinastine 5 minutes before antigen challenge showed a mean itching score of 1.14 at 5 minutes post–challenge, compared with 2.07 for eyes treated with vehicle (P = .008). The onset mean hyperemia scores at 5 minutes post–challenge were 0.86 for epinastine–treated eyes and 1.93 for vehicle–treated eyes (P = .026). In the duration of efficacy assessment, eyes treated with epinastine 12 hours before antigen challenge had a mean itching score of 1.00 at 5 minutes post–challenge, compared with 2.25 for eyes treated with vehicle (P = .011). Conclusions: Treatment with epinastine HCl 0.05% ophthalmic solution significantly reduced ocular allergy symptoms compared with vehicle in this conjunctival antigen challenge trial. Epinastine relieved ocular allergy symptoms rapidly and showed a long duration of efficacy.
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