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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02531152 | 28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension | PHASE1 | COMPLETED | 54 | — | — | Sep 1, 2015 | Apr 1, 2016 | Apr 27, 2016 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| SAR366234 (Dose 1) | EXPERIMENTAL | A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| SAR366234 (Dose 2) | EXPERIMENTAL | A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days |
| SAR366234 (Dose 3) | EXPERIMENTAL | A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| SAR366234 (Dose 4) | EXPERIMENTAL | A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days |
| SAR366234 (Dose 5) | EXPERIMENTAL | A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| Latanoprost | ACTIVE_COMPARATOR | A dose of Latanoprost will be administered 1 drop per eye per day for 28 days |
| Name | Type | Description |
|---|---|---|
| Latanoprost | DRUG | - |
| SAR366234 | DRUG | - |
Inclusion criteria: * Male or female patients ≥18 years of age. * Patients diagnosed with OAG (including pseudoexfoliation and pigment dispersion syndromes and patients with a history of narrow angle closure with a patent peripheral iridotomy) or OHT. * Documented intraocular pressure (IOP) fulfill...