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The purpose of this study is to compare the efficacy and safety of CKD-350 in patients with dry eye syndrome
Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-350 eye drops in patients with dry eye syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-350 | Experimental | Xenobella |
|
| Sodium Hyaluronate | Active Comparator | Isotonic 0.3% Sodium Hyaluronate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenobella | Drug | Hypotonic 0.3% Sodium Hyaluronate |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corneal Staining by Oxford scale from Baseline and at Week 4 | Baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corneal Staining by Oxford scale from Baseline and at Week 2 | Baseline, week 2 | |
| Changes in Tear Break-up Time from Baseline and at Week 2, 4 | Baseline, Week 2, 4 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HyoMyung Kim, MD | Korea University Anam Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Not yet recruiting | Daejeon | Chungcheongnam-do | South Korea |
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| Isotonic 0.3% Sodium Hyaluronate | Drug | Isotonic 0.3% Sodium Hyaluronate |
|
|
| Changes in Schirmer I Test from Baseline and at Week 2, 4 |
| Baseline, Week 2, 4 |
| Changes in Ocular Surface Disease Index from Baseline and at week 2, 4 | Baseline, week 2, 4 |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | South Korea |
|
| Kyungpook National University Hospital | Recruiting | Daegu | Gyeongsangbuk-do | South Korea |
|
| Pusan National University Hospital | Recruiting | Pusan | Gyeongsangnam-do | South Korea |
|
| Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | South Korea |
|
| Chonnam National University Hospital | Recruiting | Gwangju | Jeollanam-do | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | Seoul | South Korea |
|
| Gangnam Severance Hospital | Not yet recruiting | Seoul | Seoul | South Korea |
|
| Korea University ANAM Hospital | Recruiting | Seoul | Seoul | South Korea |
|
| Korea University GURO Hospital | Recruiting | Seoul | Seoul | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | Seoul | South Korea |
|
| Seoul National University Hospital | Not yet recruiting | Seoul | Seoul | South Korea |
|
| The Catholic University of Korea Seoul ST. MARY'S Hospital | Recruiting | Seoul | Seoul | South Korea |
|
| Yonsei University Severance Hospital | Recruiting | Seoul | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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