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This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | SJP002 BID |
|
| 2 | Experimental | SJP002 QID |
|
| Placebo 1 | Placebo Comparator | SJP002 Placebo 1 |
|
| Placebo 2 | Placebo Comparator | SJP002 Placebo 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJP002 BID | Drug | 1 drop b.i.d for 12 weeks |
| |
| SJP002 QID |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Fluorescein Corneal Staining(FCS) score | The degree of corneal inflammation is scored (total of 5 points) according to the Oxford grading scale from 0 (no staining, A) to 5 (severe, confluent staining, >E). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Fluorescein Corneal Staining(FCS) score | The degree of corneal inflammation is scored (total of 5 points) according to the Oxford grading scale from 0 (no staining, A) to 5 (severe, confluent staining, >E). | 2 weeks |
| Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score |
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Inclusion Criteria:
Age over 19.
Must meet all criteria listed below at least in one eye.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Choun-Ki Joo, M.D.,Ph.D. | 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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| Drug |
1 drop q.i.d for 12 weeks |
|
| SJP002 Placebo 1 | Drug | 1 drop q.i.d for 12 weeks |
|
| SJP002 Placebo 2 | Drug | 1 drop q.i.d for 12 weeks |
|
Immediately after dyeing (max within 2 minutes), Scored by using slit lamp on white light and a red barrier filte according to the Oxford scheme using a source From 0 (no staining, A) up to 5 (severe, confluent staining, >E) (10 points in total). |
| 2, 4 weeks |
| Change from baseline of Schirmer Test score | Change from Baseline, 2, 4 Weeks | 2, 4 weeks |
| Change from baseline of Tear Break-Up Time(TBUT) | Change from Baseline, 2, 4 Weeks | 2, 4 weeks |
| Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) | Change from Baseline, 4 Weeks | 4 weeks |
| Numbers of used artificial tears during the study period | Change from Baseline, 4 Weeks | 4 weeks |