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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01250171 | The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients | PHASE2 | COMPLETED | 72 | — | — | Nov 1, 2010 | Sep 1, 2011 | Jan 7, 2013 | 1 | United States |
Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.
| Arm | Type | Description |
|---|---|---|
| Secukinumab 10 mg/kg | EXPERIMENTAL | Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period. |
| Canakinumab 10 mg/kg | EXPERIMENTAL | Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period. |
| Placebo | PLACEBO_COMPARATOR | Patients received a single placebo infusion intravenously over a 2 hour period. |
| Name | Type | Description |
|---|---|---|
| Secukinumab 10 mg/kg | BIOLOGICAL | Secukinumab was prepared in a sterile water solution. |
| Canakinumab 10 mg/kg | BIOLOGICAL | Canakinumab was prepared in a sterile water solution. |
| Placebo | BIOLOGICAL | The placebo solution for infusion contained 5% glucose. |
Inclusion Criteria: * Male and female patients age 18-85 with a diagnosis of moderate to severe dry eye. * Schirmer test without anesthesia ≥ 1 and \< 10 mm wetting over 5 minutes in at least 1 eye. * Tear break up time \< 7 seconds in at least 1 eye. * Corneal staining score ≥ 3 (National Eye Inst...