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| Name | Class |
|---|---|
| GL Pharm Tech Corporation | INDUSTRY |
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This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group 1 | Experimental | (AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day |
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| Test group 2 | Experimental | (AJU-S56 5%), 1drop/1times, 6times in a day |
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| Comparator group | Placebo Comparator | Placebo(Vehicle), 1drop/1times, 6times in a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (AJU-S56 5% and placebo) | Drug | (AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Total corneal staining score (TCSS) | Total corneal staining score (TCSS) ≥4 at baseline (Total Max score : 15, bigger socre means worse outcome) | WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0) |
| Measure | Description | Time Frame |
|---|---|---|
| LGCSS | Lissamine Green Conjunctival Staining Score(Total score : 0~18) | WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0) |
| 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 |
|---|---|---|---|---|---|---|
| AJU Pharm Co., Ltd. | Seoul | South Korea |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| AJU-S56 5% | Drug | (AJU-S56 5%), 1drop/1times, 6times in a day |
|
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| Placebo(Vehicle) | Drug | Placebo(Vehicle), 1drop/1times, 6times in a day |
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| WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0) |