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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00905450 | Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery | PHASE2 | COMPLETED | 415 | — | — | Jun 1, 2009 | May 1, 2010 | Sep 22, 2020 | 1 | United States |
Anterior chamber (AC) cells will be assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. Pigment cells and red blood cells are to be ignored. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
| Arm | Type | Description |
|---|---|---|
| BOL-303242-X | EXPERIMENTAL | BOL-303242-X (Mapracorat) |
| Vehicle | PLACEBO_COMPARATOR | Vehicle for BOL-303242-X (Mapracorat) |
| Name | Type | Description |
|---|---|---|
| BOL-303242-X | DRUG | Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules. |
| Vehicle for BOL-303242-X | DRUG | Medication instilled into the study eye, subjects randomized to various drug dose schedules. |
Inclusion Criteria: * Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent. * Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC)...