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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00699153 | Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery | PHASE3 | COMPLETED | 400 | — | — | Jun 1, 2008 | Jun 1, 2009 | Mar 24, 2015 | 1 | United States |
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
| Arm | Type | Description |
|---|---|---|
| Loteprednol Etabonate | EXPERIMENTAL | Loteprednol Etabonate 0.5% |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of Ophthalmic Loteprednol Etabonate |
| Name | Type | Description |
|---|---|---|
| Loteprednol Etabonate | DRUG | Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days. |
| Vehicle of Ophthalmic Loteprednol Etabonate | DRUG | Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days. |
Inclusion Criteria: * Subjects at least 18 years of age * Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization. * Subjects who are candidate for routine, uncomplicated cataract surgery. * ...