Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is planned to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops(Cyclosporine 0.01%, 0.02%) compared to Restasis(Cyclosporine 0.05%) in Patients with Dry Eye Disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCAI-001 0.01% | Experimental | Cyclosporine 0.01% |
|
| SCAI-001 0.02% | Experimental | Cyclosporine 0.02% |
|
| Restasis | Active Comparator | Cyclosporine 0.05% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCAI-001 0.01% eyedrop | Drug | BID for 12weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear volume | Schirmer's test | Change from baseline at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tear volume | Schirmer's test | Change from baseline at 4, 8 weeks |
| Corneal staining score with fluorescein | Oxford grading | Change from baseline at 4, 8, 12 weeks |
Not provided
Inclusion Criteria:
Male and Female who over 19 years old
Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.)
Those who meet below criteria at least one of two eyes;
The corrected visual acuity is 0.2 or more.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lee, MD, PhD | Pusan National Univ. Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of korea, Bucheon ST.Mary's Hospital | Bucheon-si | South Korea | ||||
| Inje University Busan Paik Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SCAI-001 0.02% eyedrop | Drug | BID for 12weeks |
|
|
| Restasis 0.05% eyedrop | Drug | BID for 12weeks |
|
|
| conjunctival staining score with Lissamine green | Oxford grading | Change from baseline at 4, 8, 12 weeks |
| Tear film break-up time | Measured three times and recorded up to 1/100 | Change from baseline at 4, 8, 12 weeks |
| Standard patient evaluation of eye dryness questionnaire | written by the subject | Change from baseline at 4, 8, 12 weeks |
| Ocular surface disease index | written by the subject | Change from baseline at 4, 8, 12 weeks |
| Total number of rescue medication used | sourced by patient diary | 12weeks |
| Busan |
| South Korea |
| Pusan National Univ. Hospital | Busan | South Korea |
| Kyungpook National University Hospital | Daegu | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | South Korea |
| Kangbuk Samsung Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided