Yanai Kaori, Huang Jane, Kadonosono Kazuaki, Uchio Eiichi
Department of Ophthalmology, Fukuoka University School of Medicine, Fukuoka, Japan.
Clin Ophthalmol. 2013;7:741-4. doi: 10.2147/OPTH.S41801. Epub 2013 Apr 17.
To evaluate the safety of bromfenac sodium eye drops from the standpoint of corneal sensitivity and tear secretion in healthy controls following instillation for 1 month.
A prospective single-blind parallel clinical study was conducted in 20 eyes of ten healthy volunteers with no history of ocular or systemic allergic disease, dry eye, contact lens wear, or ocular surgery. Participants were instructed to instill either bromfenac sodium or artificial tears in each eye twice daily for 28 days. Corneal sensitivity tested using a Cochet-Bonnet esthesiometer was evaluated before and immediately after instillation at 7, 14, and 28 days after the initiation of treatment. Tear secretion was also evaluated by Schirmer's eye test before and at 28 days.
No significant difference in mean corneal sensitivity and tear-secretion rate was observed between the bromfenac and artificial-tear treatment groups at any time.
These results indicate that bromfenac sodium eye drops are safe with respect to corneal sensitivity and tear secretion in subjects with a normal ocular surface condition. Further evaluation is still necessary to determine whether bromfenac is safe in pathological conditions, such as inflammatory disorders and postsurgical cases.
从角膜敏感性和泪液分泌的角度,评估健康对照者滴用溴芬酸钠滴眼液1个月后的安全性。
对10名无眼部或全身过敏性疾病、干眼、佩戴隐形眼镜或眼部手术史的健康志愿者的20只眼进行前瞻性单盲平行临床研究。参与者被指示每天两次在每只眼中滴入溴芬酸钠或人工泪液,持续28天。在治疗开始后的第7、14和28天,在滴入前和滴入后立即使用科谢-博内眼压计测试角膜敏感性,并进行评估。还在第28天使用Schirmer氏试验评估泪液分泌。
在任何时间,溴芬酸钠治疗组和人工泪液治疗组之间的平均角膜敏感性和泪液分泌率均无显著差异。
这些结果表明,对于眼表状况正常的受试者,溴芬酸钠滴眼液在角膜敏感性和泪液分泌方面是安全的。仍需进一步评估以确定溴芬酸钠在炎症性疾病和术后病例等病理状况下是否安全。