[Translation] A randomized, double-blind, placebo-controlled, multicenter, phase Ib clinical trial of recombinant human nerve growth factor eye drops in the treatment of neurotrophic keratitis
主要目的
以安慰剂为对照,初步评价不同剂量rhNGF滴眼液治疗神经营养性角膜炎(NK)的有效性。
次要目的
1. 为rhNGF滴眼液后续临床试验的给药剂量提供依据。
2. 评价rhNGF滴眼液的全身药代动力学(PK)特征及免疫原性。
3. 初步评价不同剂量rhNGF滴眼液治疗神经营养性角膜炎(NK)的安全性。
[Translation] Main purpose
Using placebo as control, preliminarily evaluate the effectiveness of different doses of rhNGF eye drops in the treatment of neurotrophic keratitis (NK).
Secondary purpose
1. Provide a basis for the dosing of rhNGF eye drops in subsequent clinical trials.
2. Evaluate the systemic pharmacokinetic (PK) characteristics and immunogenicity of rhNGF eye drops.
3. Preliminarily evaluate the safety of different doses of rhNGF eye drops in the treatment of neurotrophic keratitis (NK).