Abstract
Abstract: :
Purpose: To evaluate the safety and efficacy of epinastine HCl 0.05%, a new topical ophthalmic antihistamine with mast cell–stabilizing and anti–inflammatory properties, in patients with acute seasonal allergic conjunctivitis. Methods: Participants (N = 99) in this multicenter, randomized, double–masked, parallel group environmental study were 16 years or older with acute, seasonal, allergic conjunctivitis. Ocular symptoms were recorded 3 times daily in electronic diaries. The worst daily itching and hyperemia scores over a 2–3 day period prior to randomization were 2 or greater on a scale of 0–4. On day 0, patients were randomized to receive 1 drop/eye of epinastine BID (n = 51) or ketotifen BID (n = 48) for 14 days. Efficacy was assessed by change from baseline of the worst daily score, calculated by subtracting the average of the worst daily scores over the treatment period from that of the baseline period. The study was designed to demonstrate non–inferiority of epinastine to ketotifen. Results: At baseline, mean ocular itching and hyperemia scores were 2.7 for both treatment groups; mean lid swelling scores were 1.9 for epinastine and 1.8 for ketotifen on a scale of 0–3. Mean worst daily scores for itching, hyperemia, and lid swelling over the 2–week treatment period were reduced by more than 40% in both groups (p < 0.001), with no significant difference between treatment groups. The efficacy of epinastine for symptom relief was shown to be non–inferior to that of ketotifen. In addition, 93% of epinastine patients judged the treatment "comfortable/very comfortable" 30 minutes after the instillation compared with 89% of ketotifen patients. Detailed results of the Eye Allergy Patient Impact Questionnaire (EAPIQ) will be presented in the poster. Three (5.9%) epinastine patients and 7 (14.6%) ketotifen patients experienced adverse events. Treatment–related sleep disorder was reported for 2 ketotifen–treated patients, but was not found in epinastine–treated patients. Conclusions:In this study, ophthalmic epinastine was well tolerated and provided effective relief of seasonal allergic conjunctivitis symptoms. Statistical non–inferiority analysis demonstrated that epinastine was at least as effective as ketotifen.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • conjunctivitis