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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02006888 | The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery | PHASE3 | COMPLETED | 394 | — | — | Jan 1, 2014 | Oct 1, 2014 | Apr 23, 2018 | 1 | United States |
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
| Arm | Type | Description |
|---|---|---|
| IBI-10090 low dose | EXPERIMENTAL | IBI-10090 low dose |
| IBI-10090 med dose | EXPERIMENTAL | IBI-10090 med dose |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| IBI-10090 | DRUG | - |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB). 2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intr...