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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02034019 | Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery | PHASE3 | COMPLETED | 247 | — | — | Feb 1, 2014 | Feb 1, 2015 | Jan 31, 2020 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| OTX-DP (Dexamethasone Punctum Plug) | ACTIVE_COMPARATOR | Resorbable hydrogel drug delivery vehicle containing dexamethasone |
| PVPP (Placebo Punctum Plug) | PLACEBO_COMPARATOR | Resorbable hydrogel drug delivery vehicle containing no drug |
| Name | Type | Description |
|---|---|---|
| Dexamethasone | DRUG | - |
| Punctum Plug | DRUG | - |
Inclusion Criteria: * Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens * Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes Exclusion Criteri...