drugset / Trial / NCT03192137
Study to Evaluate ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (dexamethasone in DuraSite® 2) compared with Vehicle in the treatment of inflammation and pain associated with cataract surgery.
Timeline
- Start
- 2018-01-30
- Primary completion
- 2019-04-17
- Completion
- 2019-04-17
Outcome
Met primary endpoint
registry analysis (superiority test); ISV-305 vs Vehicle; p = 0.0005; Chi-squared, Corrected NCT03192137 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 0.1 % | Topical |