drugset / Trial / NCT01165450
Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects
Phase 2
Terminated
2 enrolled
University of California, San Francisco
FDA Office of Orphan Products Development · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with persistent corneal epithelial defects (PED) resulting from corneal epithelial debridement during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or post-corneal transplant surgery.
Timeline
- Start
- 2011-11
- Primary completion
- 2014-02
- Completion
- 2014-02
Outcome
Outcome not reported
Stopped: “Drug manufacturer could not supply study drug.”
Publications
- Background Qiu C, Coutinho P, Frank S, Franke S, Law LY, Martin P, Green CR, Becker DL. Targeting connexin43 expression accelerates the rate of wound repair. Curr Biol. 2003 Sep 30;13(19):1697-703. doi: 10.1016/j.cub.2003.09.007.
- Background Lin JH, Weigel H, Cotrina ML, Liu S, Bueno E, Hansen AJ, Hansen TW, Goldman S, Nedergaard M. Gap-junction-mediated propagation and amplification of cell injury. Nat Neurosci. 1998 Oct;1(6):494-500. doi: 10.1038/2210.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CODA-001 | Unknown | 1 ug | — |
| Comparator | CODA-001 | Unknown | 3 ug | — |
| Comparator | CODA-001 | Unknown | 10 ug | — |