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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01666210 | Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery | PHASE2 | COMPLETED | 60 | — | — | Oct 1, 2012 | Aug 1, 2013 | Oct 19, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Dexamethasone Punctum Plug | ACTIVE_COMPARATOR | Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days |
| Placebo Vehicle Punctum Plug | PLACEBO_COMPARATOR | Placebo punctum plug insertion |
| Name | Type | Description |
|---|---|---|
| OTX-DP (Dexamethasone punctum plug) | DRUG | Sustained and tapered release of dexamethasone from hydrogel punctum plug |
| Placebo Vehicle Punctum Plug | DRUG | Hydrogel punctum plug without dexamethasone |
Inclusion Criteria: * Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule * Is greater than or equal to 21 years of age * Has a cataract and is expected to undergo clear corneal cataract surg...