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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03531697 | Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery | PHASE1 | COMPLETED | 381 | — | — | Apr 26, 2018 | Oct 7, 2019 | Nov 6, 2019 | 1 | Canada |
PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.
PK for loteprednol etabonate concentrations in aqueous humor. Maximum observed mean concentration in aqueous humor over the time span specified.
| Arm | Type | Description |
|---|---|---|
| Generic Loteprednol Etabonate - RLD | EXPERIMENTAL | Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD) |
| RLD - Generic Loteprednol Etabonate | ACTIVE_COMPARATOR | Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate |
| Name | Type | Description |
|---|---|---|
| Generic Loteprednol Etabonate | DRUG | Drug |
| Reference Listed Drug (RLD) | DRUG | Drug |
Inclusion Criteria: * Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes. * Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (h...