Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02104388 | Safety and Efficacy Study of SJP-0035 Ophthalmic Solution in Patients With Moderate to Severe Corneal Epithelial Disorders | PHASE2 | COMPLETED | 69 | — | — | Apr 8, 2014 | Aug 4, 2015 | Mar 29, 2021 | 17 | United States |
A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared.
| Arm | Type | Description |
|---|---|---|
| SJP-0035 Ophthalmic Solution | EXPERIMENTAL | Patients randomized to the SJP-0035 Ophthalmic solution will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks. |
| Vehicle of SJP-0035 Ophthalmic Solution | PLACEBO_COMPARATOR | Patients randomized to the placebo arm will receive 1 drop in the affected eye(s) given 4 times daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| SJP-0035 Ophthalmic Solution | DRUG | - |
| Vehicle of SJP-0035 Ophthalmic Solution | DRUG | - |
Inclusion Criteria: * Male or female between the ages of 18 and 75 years, inclusive. * Has moderate to severe superficial punctate keratitis (SPK) and/or corneal erosion in 1 or both eyes. * Has symptoms caused by corneal epithelial disorders. * Has not obtained improvement from previous treatment ...