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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 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group(AJU-S56 5%) | Experimental | QID(4 times in a day) for 24 Weeks after Randomization |
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| Placebo group(Vehicle) | Placebo Comparator | QID(4 times in a day) for 24 Weeks after Randomization |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AJU-S56 5% | Drug | After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24). |
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| Measure | Description | Time Frame |
|---|---|---|
| Total corneal staining score (TCSS) | TCSS ≥4 at baseline (Total Max score : 15) | WEEK 4, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| LGCSS | Lissamine Green Conjunctival Staining Score(Total score : 0~18) | WEEK 4, 8, 12 |
| TFBUT | Tear Film Break Up Time | WEEK 4, 8, 12 |
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Inclusion Criteria:
Male and Female who over 19 years old
Moderate to Severe Dry Eye Disease Patients
Must meet all criteria listed below at least in one eye or both eyes.
Written informed consent to participate in the trial
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JUNNGMIN LEE | Contact | +82-02-2630-0700 | ajuf13001@ajupharm.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AJU Pharm Co., Ltd. | Recruiting | 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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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Placebo Group(Vehicle) | Drug | After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24). |
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| D008722 | Methods |