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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 score | Change in corneal staining score assessed on Oxford grading at 12 weeks compared to baseline - Oxford grading: 0(Absent) to 5(Severe) | 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in corneal staining score | Change in corneal staining score assessed on Oxford grading at 4, 8 weeks compared to baseline | 4, 8weeks |
| Change from baseline in conjuctival staining score |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun young Hyun | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyeongsang National University Hospital | Jinju | 52727 | 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 Eye drop | Drug | trehalose 3% |
|
Change in conjuctival staining score assessed on Oxford grading at 4, 8, 12 weeks compared to baseline
| 4, 8, 12weeks |
| Change from baseline in strip meniscometry score | Change in strip meniscometry score at 4, 8, 12 weeks compared to baseline | 4, 8, 12weeks |
| Change from baseline in TBUT score | Change in TBUT score at 4, 8, 12 weeks compared to baseline | 4, 8, 12weeks |
| Change from baseline in SPEED dry eye questionnaire score | Change in SPEED dry eye questionnaire score at 4, 8, 12 weeks compared to baseline | 4, 8, 12weeks |
| Time to achieve 100% clearance in corneal staining | Time to achieve 100% clearance in corneal staining up to 12 weeks | 12weeks |
| D000602 |
| Amino Acids, Peptides, and Proteins |