drugset / Trial / NCT01579565
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
Timeline
- Start
- 2012-04
- Primary completion
- 2012-11
- Completion
- 2013-01
Outcome
Met primary endpoint
registry OMS302 vs Placebo; p = 0.0001; Mean Difference (Final Values) 0.590 (95% CI 0.494 to 0.686) NCT01579565 ↗
registry OMS302 vs Placebo; p = 0.0002; Mean Difference (Final Values) -4.580 (95% CI -6.917 to -2.244) NCT01579565 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketorolac | Other / unclassified | — | Other |
| Subject | Phenylephrine | Small molecule | — | Other |
Indications
No indication recorded.