Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of KSR-001.
After single dose, safety and local tolerability were confirmed and repeated test was conducted according to the investigator's judgment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSR-001-01 | Experimental | Participants received KSR-001-01 for 6 days. |
|
| KSR-001-02 | Experimental | Participants received KSR-001-02 for 6 days. |
|
| KSR-001-03 | Experimental | Participants received KSR-001-03 for 6 days. |
|
| KSR-001-04 | Placebo Comparator | Participants received KSR-001-04 for 6 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSR-001 | Drug | (0 day) eye drops received one drop to both eyes once a day (1~5 day) eyedrops recieved one drop to both eyes four times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetic Characteristics | 6 days |
| Tmax | Pharmacokinetic Characteristics | 6 days |
| t1/2 | Pharmacokinetic Characteristics | 6 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kukje Pharma | Seongnam-si | South Korea |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| KSR-004 | Drug | (0 day) eye drops received one drop to both eyes once a day (1~5 day) eyedrops recieved one drop to both eyes four times a day |
|
| KSR-001-02 | Drug | KSR-001-02 |
|
| KSR-001-03 | Drug | KSR-001-03 |
|