drugset / Trial / NCT01440751
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery
Phase 4
Completed
99 enrolled
Aeon Astron Europe B.V.
Robert Ritch, MD, LLC. · collabThe New York Eye & Ear Infirmary · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.
Timeline
- Start
- 2011-09
- Primary completion
- 2013-12
- Completion
- 2015-12
Publications
- Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
- Tanna AP, Rademaker AW, de Moraes CG, Godfrey DG, Sarkisian SR Jr, Vold SD, Ritch R. Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial. BMC Ophthalmol. 2016 Dec 29;16(1):217. doi: 10.1186/s12886-016-0393-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mitomycin C | Other / unclassified | 15 ug | Topical |
| Comparator | Mitomycin C | Other / unclassified | 0.4 mg/ml | Topical |