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An investigator-initiated single-center, randomized, double-blind, placebo-controlled clinical study .The main purpose is to evaluate the effectiveness of ZKY001 eye drops in treating corneal epithelial defects caused by neurotrophic keratitis in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.002% ZKY001 eye drops(Herpes simplex keratitis group) | Experimental | NK caused by Herpes simplex keratitis 0.002% ZKY001 eye drops,1 drop each time, 4 times a day. Start on D1, continuously for 56±3 days. It is recommended that the eye drops be taken at intervals of 4 to 6 hours. |
|
| Vehicle(Herpes simplex keratitis group) | Placebo Comparator | NK caused by Herpes simplex keratitis Vehicle,1 drop each time, 4 times a day. Start on D1, continuously for 56±3 days. It is recommended that the eye drops be taken at intervals of 4 to 6 hours. |
|
| 0.002% ZKY001 eye drops(Diabetes group) | Experimental | NK caused by diabetes 0.002% ZKY001 eye drops,1 drop each time, 4 times a day. Start on D1, continuously for 56±3 days. It is recommended that the eye drops be taken at intervals of 4 to 6 hours. |
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| Vehicle(Diabetes group) | Placebo Comparator | NK caused by diabetes Vehicle,1 drop each time, 4 times a day. Start on D1, continuously for 56±3 days. It is recommended that the eye drops be taken at intervals of 4 to 6 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZKY001 eye drops | Drug | Administer to eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with corneal epithelial healing(<0.5 mm lesion size) at D57. | corneal epithelial healing(<0.5 mm lesion size) | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of corneal healing (<0.5 mm lesion size). | corneal healing (<0.5 mm lesion size). | D57 |
| Percentage of improvement in corneal epithelial defect from baseline at D29、D57 | improvement in corneal epithelial defect |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Eye Center of Xiamen University | Xiamen | Fujian | China |
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| Vehicle (placebo) | Drug | Administer to eyes |
|
| D29、D57 |
| Improvement in corneal fluorescein staining scores from baseline at D29、D57 | Improvement in corneal fluorescein staining scores | D29、D57 |
| Improvement in corneal sensitivity from baseline at D29、D57 | Improvement in corneal sensitivity | D29、D57 |