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A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. The study included two experimental groups (low-dose ZKY001 eye drops group and medium-dose ZKY001 eye drops group) and a placebo control group, with 60 subjects in each group.
Each subject had the study drug instilled into the study eye according to the randomly obtained drug number.
Duration OF THE STUDY:The screening period was D-5 to D-1, the experimental period was D0 (the day of operation) to D5, and the observation period was D10±2.
Statistical analyses were performed with the use of SAS software (version 9.4 or higher) without special instructions. All statistical tests were two-sided, with a significance level of 0.05. Enrollment analysis: the number of enrolled and completed cases in each center was summarized, and the list of dropped cases was made. Overall dropout rates in each group and dropout rates related to adverse events were compared between groups with the use of the chi-square test or Fisher's exact test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial drug group 1 | Experimental | lowe-dose ZKY001 eye drops |
|
| Trial drug group 2 | Experimental | Medium-dose ZKY001 eye drops |
|
| control group | Placebo Comparator | ZKY001 simulated eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lowe-dose ZKY001 eye drops | Drug | eye drops |
| |
| Medium-dose ZKY001 eye drops |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal epithelial defect repair area | Percentage improvement of corneal epithelial defect area from baseline in the afternoon of D3 | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| VAS score | the mean change of VAS scores from baseline in D3 and D5 | 5 days |
| Best Corrected Visual acuity (BCVA) | The mean change of best corrected visual acuity at D1, D3, and D5 from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Hospital of Shandong First Medical University (Shandong Eye Hospital) | Jinan | Shandong | China |
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| Drug |
eye drops |
|
| ZKY001 simulated eye drops | Drug | eye drops |
|
| 5 days |