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A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, 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 | Experimental | Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks |
|
| Restasis | Active Comparator | Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks |
|
| Moisview | Active Comparator | trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HU007 | Drug | cyclosporine 0.02%, trehalose 3% |
| |
| Restasis |
| Measure | Description | Time Frame |
|---|---|---|
| change from Baseline in Corneal staining(Oxford grading) score | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| change from Baseline in Corneal staining(Oxford grading) score | Week 4,8 | |
| change from Baseline of Conjunctival staining(Oxford grading) score | Week 4,8,12 | |
| change from Baseline of Strip meniscometry assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Namsick Kim | Huons Co., Ltd. | Study Director |
| Choun-Ki Joo | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul ST.Mary's Hospital | 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 |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Drug |
cyclosporine 0.05% |
|
| Moisview | Drug | trehalose 3% |
|
| Week 4,8,12 |
| change from Baseline of Tear film break-up time | Week 4,8,12 |
| change from Baseline of Standard patient evaluation of eye dryness questionnaire | Week 4,8,12 |
| arrival time of 100% clearence in Corneal staining test | Week 0-12 |
| The number of total rescue drug usage | Week 0-12 |
| D000602 |
| Amino Acids, Peptides, and Proteins |