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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02128113 | RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD | PHASE2 | COMPLETED | 307 | — | — | May 31, 2014 | Apr 30, 2015 | Jun 3, 2025 | 15 | United States |
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
| Arm | Type | Description |
|---|---|---|
| Vehicle Ophthalmic Solution | PLACEBO_COMPARATOR | A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery |
| Omaveloxolone Opthalmic Suspension 0.5% | EXPERIMENTAL | A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery |
| Omaveloxolone Opthalmic Suspension 1% | EXPERIMENTAL | A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery |
| Name | Type | Description |
|---|---|---|
| Vehicle Ophthalmic Solution | DRUG | Opthalmic suspension manufactured to mimic RTA 408 suspension |
| Omaveloxolone Ophthalmic Suspension 0.5% | DRUG | 0.5% ophthalmic suspension of RTA 408 |
| Omaveloxolone Ophthalmic Suspension 1% | DRUG | 1% ophthalmic suspension of RTA 408 |
Inclusion Criteria: 1. Be male or female and ≥18 years of age and ≤80 years of age 2. Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens 3. Have the potential, in the opinion of the investigator, to improve best-corrected visual ...