A Phase 2 interventional study of ZKY001 eye drops 0.3g:0.006mg and ZKY001 eye drops 0.3g:0.012mg in Corneal Defect, sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Phase 2, Interventional, and Treatment
The subjects of this study were patients who underwent corneal endothelial transplantation,who were randomly divided into 3 groups, 2 groups (0.002% and 0.004% ZKY001 eye drops) and 1 placebo control group.
This study is an exploratory phase II clinical study with no sample size estimation.According to the results of the preliminary animal experiments and phase I clinical trials, 2 concentrations (0.002% and 0.004%ZKY001eye drops) were selected as the experimental group, and 1 placebo control group was selected, with 35 subjects in each group and a total of 105 subjects.Each subject will drop the study drug into the test eye (the surgical eye is taken as the test eye) according to the randomly assigned drug number.
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Experimental group A: 35 subjects .0.002% ZKY001 eye drops . 4 times a day,1 drop every time, continuously administered for 14±2 days ZKY001 eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).
Drug: ZKY001 eye drops 0.3g:0.006mg
Experimental group B: 35 subjects .0.004% ZKY001 eye drops . 4 times a day,1 drop every time, continuously administered for 14±2 days ZKY001 eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).
Drug: ZKY001 eye drops 0.3g:0.012mg
Placebo group C: ZKY001 simulated eye drops .4 times a day,1 drop every time, continuously administered for 14±2 days ZKY001 simulated eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).
Drug: ZKY001 simulated eye drops
ZKY001 eye drops of 0.002% continuously for up to 14±2 days after Corneal endothelial transplantation
Also known as: shengfatai-eye drops, the Germinal Peptide eye drops
ZKY001 eye drops of 0.004% continuously for up to 14±2 days after Corneal endothelial transplantation
Also known as: shengfatai-eye drops, the Germinal Peptide eye drops
ZKY001 simulated eye drops continuously for up to 14±2 days after Corneal endothelial transplantation
Also known as: the placebo
The change of corneal epithelial defect area on Day 3 compared with that on baseline will be calculated by the grid method
Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1（the first day after surgery,baseline），Day3 (the third day after surgery).After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Improvement in epithelial defect area = defect area on baseline - defect area on Day3
Time frame: Day 3, 8:00 am±1hour
The subject's symptoms and signs will be evaluated on the General Arbitroid
Subjects' symptoms and signs were evaluated on the general symptom and signs scale at Day1 before fluorescein staining of the cornea. The mean change of the total score of symptoms and signs on Day 3、Day6 、Day15 after the operation compared with the baseline
Time frame: Day 3, Day6 、Day15 8:00 am±1hour
Scoring with D6 and D15 corneal fluorescein staining
Subjects underwent corneal fluorescein staining and scoring before the first dose of Day1, Day6 and Day15
Time frame: Day6 、Day15 8:00 am±1hour
The improvement rate of corneal epithelial defect area on Day 3 postoperation after surgery compared with that at baseline (Day1 postoperation ) will be calculated by the grid method
Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1（the first day after surgery,baseline），Day3 (the third day after surgery).After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Improvement rate of corneal epithelial defect area=( defect area at baseline - defect area at Day3)/defect area at baseline ✖100%
Time frame: Day 3, 8:00 am±1hour
The change of corneal epithelial defect area on Day 2、Day4、Day5 compared with that on baseline(Day 1) will be calculated by the grid method
Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1，Day 2、Day4、Day5.After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Day2 Improvement in epithelial defect area = defect area on baseline - defect area on Day2 Day4Improvement in epithelial defect area = defect area on baseline - defect area on Day4 Day5 Improvement in epithelial defect area = defect area on baseline - defect area on Day5
Time frame: Day 2、Day4、Day5 8:00 am±1hour
The incidence of reexfoliation of corneal epithelium was observed
incidence of re-exfoliation of corneal epithelium on Day3、Day4、Day5、Day6、Day15±2 In the process of corneal epithelium repair, the epithelium may reexfoliate after covering the wound.Reexfoliation of the corneal epithelium was defined as positive corneal fluorescein staining under slit lamp microscope，Corneal fluorescein staining was performed before the first administration
Time frame: Day 3, Day4，Day5，Day6，Day15±2 8:00 am±1hour
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Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.