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This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, Phase III Study to evaluate the efficacy and safety of HU007 eye drops in patients With dry eye syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HU007 Eye drop | Experimental | Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H) |
|
| Restasis Eye drop 0.05% (Cyclosporine) | Active Comparator | Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HU007 | Drug | Cyclosporine 0.02% with Trehalose 3% |
| |
| Restasis eye drop |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in corneal staining score-Oxford grading | Change from baseline in corneal staining score-Oxford grading at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in corneal staining score-Oxford grading | Change from baseline in corneal staining score-Oxford grading at Week 4, 8 | Week 4, 8 |
| Change from baseline in conjunctival staining score-Oxford grading |
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Inclusion Criteria:
Male and Female who over 19 years old
Those who meet below criteria at least one of two eyes
Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period
Those who could understand this study and agree to informed consent voluntarily
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | South Korea |
IPD would be substituted for screening or random No.
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Drug |
Cyclosporine 0.05% |
|
Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12
| Week 4, 8, 12 |
| Change from baseline in strip meniscometry | Change from baseline in strip meniscometry at Week 4, 8, 12 | Week 4, 8, 12 |
| Change from baseline in Tear film break-up time | Change from baseline in Tear film break-up time at Week 4, 8, 12 | at Week 4, 8, 12 |
| Change from Baseline of Standard patient evaluation of eye dryness questionnaire | Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12 | at Week 4, 8, 12 |
| Time to achieve 100% clearance on the corneal staining score | Time to achieve 100% clearance on the corneal staining score | upto week 12 |