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One dose group of 0.004% was used.
One dose group of 0.004% was used. The whole study includes two stages: pre-test and formal test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.004% ZKY001 eye drops | Experimental | Start taking the medicine from Day 1 and continue for 6 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZKY001 EYE DROPS | Drug | On the 1st postoperative day (Day1), ZKY001 eye drops were dropped into the experimental eyes (the operative eyes were taken as the experimental eyes). ZKY001 eye drops were given at 8:00 am ±1h from Day1 to Day5. 4 times a day, 1 drop each time, recommended interval of 4 to 6 hours. Day6 was administered at 8:00 am ±1h, and ZKY001 eye drops were dropped into the test eye (the surgical eye was taken as the test eye). Day6 was given only once, 1 drop each time. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Area Under Curve from 0 to time t（AUC 0-t）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Area Under Curve from 0 to infinity（AUC 0-∞）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Area Under Curve at steady state（AUC ss）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Maximum Plasma Concentration（C max）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Minmum Plasma Concentration（C min）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Average Plasma Concentration（C av）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Degree of fluctuation（FD）） were estimated based on plasma concentration of ZKY001 after multiple dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiqiang Pan | Beijing Tongren Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhiqiang Pan | Beijing | BJ10 | China |
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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A dose group of 0.004% was used
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| Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Maximum Time（T max）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（half time（T 1/2）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（apparent volume of distribution（Vd）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（elimination rate constant（Kel）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Mean Residence Time（MRT）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Clearance（CL）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |
| Estimate pharmacokinetic parameters | Pharmacokinetic parameters（Clearance/Bioavailability（CL/F）） were estimated based on plasma concentration of ZKY001 after multiple dosing | Day 6 |