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A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.
Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end of the study on D7.
Statistical analysis was performed using SAS9.4 or above software. All statistical tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lowe-dose ZKY001 eye drops | Experimental | The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6 |
|
| Medium-dose ZKY001 eye drops | Experimental | The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6 |
|
| placebo | Placebo Comparator | The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lowe-dose ZKY001 eye drops | Drug | eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| healing time | Corneal epithelial healing time | seven days |
| Measure | Description | Time Frame |
|---|---|---|
| number of healing | The percentage of corneal healing at 24h, 48h, 72h, 120h and 168h after operation | seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal staining | The percentage of corneal staining negative at 48h, 72h, 120h and 168h after surgery | seven days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xingtao Zhou | Eye & ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
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| Medium-dose ZKY001 eye drops | Drug | eye drops |
|
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| placebo | Drug | eye drops |
|
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