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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04630158 | Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP) | PHASE2 | COMPLETED | 153 | — | — | Apr 21, 2021 | Jun 8, 2023 | Oct 9, 2024 | 28 | United States, Japan +1 |
The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome.
| Arm | Type | Description |
|---|---|---|
| SAF312 Placebo | PLACEBO_COMPARATOR | Randomized to a 1:1:1 topical eye drops, twice daily |
| SAF312 5 mg/mL | EXPERIMENTAL | Randomized to a 1:1:1 topical eye drops, twice daily |
| SAF312 15 mg/mL | EXPERIMENTAL | Randomized to a 1:1:1 topical eye drops, twice daily |
| Name | Type | Description |
|---|---|---|
| SAF312 Placebo | OTHER | Topical ocular, suspension eye drops |
| SAF312 | DRUG | Topical ocular, suspension eye drops |
Key Inclusion Criteria: * Subjects who have undergone refractive surgery (i.e., PRK, LASIK, LASEK, RK, or SMILE) in both eyes or cataract surgery in both eyes, with or without refractive enhancement in one or both eyes, ≥4 months prior to Screening Visit and experiencing persistent ocular surface p...