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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01591161 | Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery | PHASE3 | COMPLETED | 369 | — | — | Jul 1, 2012 | Jul 1, 2013 | Sep 3, 2020 | 1 | United States |
| NCT01591655 | Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery | PHASE3 | COMPLETED | 360 | — | — | Jul 1, 2012 | Oct 1, 2013 | Sep 3, 2020 | 1 | United States |
| NCT01230125 | Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery | PHASE3 | COMPLETED | 311 | — | — | Nov 1, 2010 | Aug 1, 2011 | Sep 3, 2020 | 1 | United States |
Anterior chamber (AC) cells were 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. 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.
Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, where higher scores indicated worse pain.
Anterior chamber (AC) cells were 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. 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 |
|---|---|---|
| Mapracorat | EXPERIMENTAL | Mapracorat ophthalmic suspension, 3%, |
| Vehicle | PLACEBO_COMPARATOR | The vehicle of the mapracorat ophthalmic suspension |
| Name | Type | Description |
|---|---|---|
| Mapracorat | DRUG | 1 drop of study medication into the study eye QID for 14 days |
| Placebo | DRUG | 1 drop of vehicle into the study eye QID for 14 days. |
| Vehicle | DRUG | 1 drop of vehicle into the study eye QID for 14 days. |
Inclusion Criteria: * Subjects who are candidates for routine, uncomplicated cataract surgery. * Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye. * Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in...