Kuna Piotr, Jutel Marek, Pulka Grazyna, Tokarski Slawomir, Arranz Paula, Hernández Gonzalo, Fernández Hernando Nieves
Department of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland.
Department of Clinical Immunology, Wroclaw Medical University, Wrocław, Poland.
Clin Ophthalmol. 2023 Mar 4;17:735-746. doi: 10.2147/OPTH.S398168. eCollection 2023.
The objective of this study was to assess the safety and tolerability of preservative-free bilastine 0.6% ophthalmic solution after 8 weeks of once-daily administration in patients with allergic conjunctivitis (AC).
Multi-center, international, randomized, double blind, placebo-controlled, parallel-group, phase III study of adult patients with seasonal or perennial AC. The study was conducted in 26 centers of 5 European countries. Duration of daily treatment with bilastine 0.6% ophthalmic solution or placebo was 8 weeks. Safety was evaluated by analyzing incidence of ocular treatment-emergent adverse events (TEAEs); additionally, and as secondary parameters, ocular tolerability was assessed, in addition efficacy was also assessed by the average daily total eye symptoms score (TESS).
A total of 333 randomized patients with AC were included (bilastine, N=218; placebo, N=115). Mean (SD) age of the patients was 39.9 (13.7) and were 63.7% female. Overall, the percentage of ocular related TEAEs was low, and the percentage of patients with ocular related TEAEs was lower in the bilastine ophthalmic solution group (2.8%) than in the placebo group (4.3%). No severe TEAEs were reported. The ocular symptoms and TESS improved during the trial in both treatment groups. Statistically significant treatment differences were observed at Week 8 for the TESS and all individual ocular symptoms, being significantly better in the bilastine ophthalmic solution group than in placebo group.
Bilastine 0.6% ophthalmic solution revealed no safety concerns in patients with AC after 8 weeks of once-daily administration. Bilastine was effective in reducing ocular symptoms associated with AC in response to both seasonal and perennial allergens.
本研究的目的是评估0.6%不含防腐剂的比拉斯汀滴眼液在过敏性结膜炎（AC）患者中每日一次给药8周后的安全性和耐受性。
一项针对季节性或常年性AC成年患者的多中心、国际性、随机、双盲、安慰剂对照、平行组III期研究。该研究在5个欧洲国家的26个中心进行。使用0.6%比拉斯汀滴眼液或安慰剂进行每日治疗的持续时间为8周。通过分析眼部治疗中出现的不良事件（TEAE）的发生率来评估安全性；此外，作为次要参数，还评估了眼部耐受性，同时通过每日平均眼部总症状评分（TESS）评估疗效。
共纳入333例随机分组的AC患者（比拉斯汀组，N = 218；安慰剂组，N = 115）。患者的平均（标准差）年龄为39.9（13.7）岁，女性占63.7%。总体而言，眼部相关TEAE的百分比很低，比拉斯汀滴眼液组眼部相关TEAE患者的百分比（2.8%）低于安慰剂组（4.3%）。未报告严重TEAE。在试验期间，两个治疗组的眼部症状和TESS均有所改善。在第8周时，TESS和所有个体眼部症状均观察到具有统计学意义的治疗差异，比拉斯汀滴眼液组明显优于安慰剂组。
0.6%比拉斯汀滴眼液在每日一次给药8周后，在AC患者中未发现安全问题。比拉斯汀在减轻与季节性和常年性过敏原相关的AC眼部症状方面有效。
