drugset / Trial / NCT05411367
A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye
Phase 3
Completed
232 enrolled
Seikagaku Corporation
ORA, Inc. · collabStatistics & Data Corporation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye
Timeline
- Start
- 2022-07-28
- Primary completion
- 2023-03-02
- Completion
- 2023-04-27
Outcome
Missed primary endpoint
registry analysis (superiority test); SI-614 vs Placebo; p = 0.315; Mean Difference (Net) -0.12 (95% CI -0.62 to 0.38); ANCOVA NCT05411367 ↗
release “SI-614 (treatment for dry eye: developed in the U.S.) Statistically significant improvement in the primary endpoint of a Phase III clinical study being conducted since May 2022 was not observed.” seikagaku.co.jp ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CINHYALURONATE SODIUM | Unknown | — | Other |