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This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.
The primary objective is to evaluate the superiority of LPTAT to placebo in slowing myopia progression through the change of SE(Spherical Equivalent), which is measured by cycloplegic autorefraction after 12-month treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Arm 1 | Experimental | LPTAT01 |
|
| Test Arm 2 | Experimental | LPTAT02 |
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| Test Arm 3 | Experimental | LPTAT03 |
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| Reference Arm | Placebo Comparator | LPTAT04 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine Sulfate 01 | Drug | Atropine sulfate 01 ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spherical Equivalent over 12-month | Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spherical Equivalent | Change in spherical equivalent measured by cycloplegic autorefraction at 4, 8 months after administration of clinical trial drug compared to baseline | 4, 8 months |
| Change in Axial length (mm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GH KIM | Contact | 82-70-8805-9682 | ghkim@litepharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Sei Yeul Oh | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Recruiting | Busan | 49241 | South Korea |
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| Atropine Sulfate 02 | Drug | Atropine sulfate 02 ophthalmic solution |
|
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| Atropine Sulfate 03 | Drug | Atropine sulfate 03 ophthalmic solution |
|
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| Placebo | Drug | Placebo ophthalmic solution |
|
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Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline
| 4, 8, 12 months |
| Inje University Busan Paik Hospital | Recruiting | Busan | South Korea |
|
| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
|
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
|
| Chung-Ang University Gwang Myeong hospital | Recruiting | Gwangmyeong | South Korea |
|
| Gachon University Gil Hospital | Recruiting | Incheon | 21565 | South Korea |
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| HanGil Eye Hospital | Recruiting | Incheon | South Korea |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | South Korea |
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| Kim'S Eye Hospital | Recruiting | Seoul | 07301 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Seoul Asan Medical Center | Recruiting | Seoul | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| The Catholic University of Korea Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| Ajou University Hospital | Recruiting | Suwon | South Korea |
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| Yongin Severance Hospital | Recruiting | Yongin | South Korea |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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