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This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KL7016 900mg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| KL7016 600mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KL7016 900mg | Drug | oral administration, 150mg 3tab, bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in corneal staining score | baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in schirmer test score | baseline, 4weeks, 8weeks, 12 weeks | |
| Change in OSDI(Ocular Surface Disease Index) | baseline, 4weeks, 8weeks, 12 weeks | |
| Change in TFBUT(Tear Film Break-up Time) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Banpo-daero, Seocho-gu | 137-701 | South Korea | ||
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| KL7016 600mg |
| Drug |
oral administration, 150mg 3tab, bid |
|
| Placebo | Drug | oral administration, 150mg 3tab, bid |
|
| baseline, 4weeks, 8weeks, 12 weeks |
| Change in conjunctival staining score | baseline, 4weeks, 8weeks, 12 weeks |
| Change in corneal staining score | baseline, 4weeks, 8weeks |
| Gangnam Severance Hospital |
| Seoul |
| Eonju-ro, Gangnam-gu |
| 135-720 |
| South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | Gumi-ro 173 Beon-gil Bundang-gu | 463-707 | South Korea |
| Korea University Guro Hospital | Seoul | Gurodong-ro, Guro-gu | 152-703 | South Korea |
| Samsung Medical Center | Seoul | Irwon-ro, Gangnam-gu | 135-710 | South Korea |
| Chonnam National University Hospital | Gwangju | Jebong-ro, Dong-gu | 501-757 | South Korea |
| Konkuk University Medical Center | Seoul | Neungdong-ro, Gwangjin-gu | 143-729 | South Korea |
| ASAN Medical Center | Seoul | Olympic-ro 43-gil, Songpa-gu | 138-736 | South Korea |
| Severance Hospital | Seoul | Yonsei-ro, Seodaemun-gu | 120-752 | South Korea |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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