RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
Summary
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
Timeline
- Start
- 2014-02-28
- Primary completion
- 2014-09-30
- Completion
- 2014-09-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Omaveloxolone Ophthalmic Suspension 1.0% vs Placebo; p = 0.4543; Difference in proportion of patients -1.2 (95% CI -21.3 to 18.9); Chi-squared NCT02065375 ↗
registry analysis (superiority test); Omaveloxolone Ophthalmic Suspension 0.5% vs Placebo; p = 0.2297; Difference in proportion of patients 8.2 (95% CI -13.5 to 29.8); Chi-squared NCT02065375 ↗
registry analysis (superiority test); Omaveloxolone Ophthalmic Suspension 1.0% vs Placebo; p = .0280; Difference in proportion of patients -21.6 (95% CI -43.1 to 0.00); Chi-squared NCT02065375 ↗
registry analysis (superiority test); Omaveloxolone Ophthalmic Suspension 0.5% vs Placebo; p = 0.0192; Difference in proportion of patients -24.0 (95% CI -45.8 to -2.2); Chi-squared NCT02065375 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omaveloxolone | Small molecule | 0.5 % | Other |
| Subject | Omaveloxolone | Small molecule | 1 % | Other |