[Translation] Phase IV, 8-week, multicenter, open-label, prospective study with 48-week follow-up to evaluate the efficacy, safety, and pharmacokinetics of cenegermin eye drops (Oxervate® 1ml: 20μg) in Chinese patients with moderate or severe neurotrophic keratitis (NK)
本研究的主要目的为评估欧适维® 在真实世界临床实践中用于治疗中度或重度神经营养性角膜炎(NK)的疗效和安全性。
拟定的疗效评价为:
1.研究者使用角膜荧光素染色评估的中度(持续性角膜上皮缺损)或重度(角膜溃疡)神经营养性角膜炎(NK)完全愈合(使用牛津量表)
2. 随访期间完全愈合的持续性
3. 角膜知觉的改善
本研究的次要目的是深入了解这种局部治疗方式在真实世界临床实践中的使用情况,评估中国人群中欧适维® 的药代动力学特征和全身暴露情况
[Translation] The primary objective of this study is to evaluate the efficacy and safety of Oxervate® for the treatment of moderate or severe neurotrophic keratitis (NK) in real-world clinical practice.
The proposed efficacy evaluations are:
1. Complete healing of moderate (persistent corneal epithelial defect) or severe (corneal ulcer) neurotrophic keratitis (NK) assessed by the investigator using corneal fluorescein staining (using the Oxford scale)
2. Durability of complete healing during follow-up
3. Improvement of corneal perception
The secondary objectives of this study are to gain a deeper understanding of the use of this topical treatment in real-world clinical practice and to evaluate the pharmacokinetic characteristics and systemic exposure of Oxervate® in the Chinese population