Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1360-8040-3073-4190 | Other Identifier | Korea Food and Drug Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BTO Pharm. Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.
This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.
Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haporine-S | Experimental | Moderate to severe dry patients administered with with Haporine-S |
|
| Restasis, Cyclosporine 0.05% | Active Comparator | Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haporine-S | Drug | 1 or 2 drops twice a day at 12 hour interval for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal staining | Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index(OSID) | Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks |
| Tear Breakup Time(TBUT) | Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse Event will be assessed for the whole study period(1 year). | 1 year |
| Serious Adverse Events | Serious Adverse Event will be assessed for the whole study period(1 year). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hyo-Myung KIM, MD, PhD | Korea University Anam Hospital | Principal Investigator |
| Jong Suk SONG, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Hyung Keun LEE, MD, PhD | Yonsei University Gangnam Severance Hospital | Principal Investigator |
| Jong-Soo LEE, MD, PhD | Busan National University Hospital | Principal Investigator |
| Mee Kum KIM, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Myoung-Joon KIM, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan National University Hospital | Busan | Busan | 602-739 | South Korea | ||
| Seoul National University Hospital |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Restasis (cyclosporine 0.05%) |
| Drug |
1 or 2 drops twice a day at 12 hour interval for 12 weeks |
|
| 0 day, 4 weeks and 12 weeks |
| Schirmer score | Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks |
| Drug compliance | Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks |
| DEWS(Dry Eye WorkShop) level | Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks |
| 1 year |
| Seoul |
| Seoul |
| 110-744 |
| South Korea |
| Yonsei University Gangnam Severance Hospital | Seoul | Seoul | 135-720 | South Korea |
| Korea University Anam Hospital | Seoul | Seoul | 136-705 | South Korea |
| Asan Medical Center | Seoul | Seoul | 138-736 | South Korea |
| Korea University Guro Hospital | Seoul | Seoul | 152-703 | South Korea |
| D000602 |
| Amino Acids, Peptides, and Proteins |