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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01010633 | Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery | PHASE3 | COMPLETED | 406 | — | — | Nov 1, 2009 | Aug 1, 2010 | Jan 9, 2012 | 1 | United States |
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
| Arm | Type | Description |
|---|---|---|
| Loteprednol Etabonate | EXPERIMENTAL | Loteprednol etabonate |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of loteprednol etabonate |
| Name | Type | Description |
|---|---|---|
| Vehicle of Loteprednol Etabonate | DRUG | 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days. |
| Loteprednol Etabonate | DRUG | 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days. |
Inclusion Criteria: * Subjects who are at least 18 years of age. * Subjects who are candidates for routine, uncomplicated cataract surgery. * Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye. Exclusion...