drugset / Trial / NCT02101359
Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.
Timeline
- Start
- 2011-06
- Primary completion
- 2013-01
- Completion
- 2013-05
Publications
- Labetoulle M, Behndig A, Tassignon MJ, Nuijts R, Mencucci R, Guell JL, Pleyer U, Szaflik J, Rosen P, Berard A, Chiambaretta F, Cochener-Lamard B; Intracameral Mydrane (ICMA), Ethics Group. Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients. BMC Ophthalmol. 2020 Mar 3;20(1):81. doi: 10.1186/s12886-020-01343-x.
- Labetoulle M, Findl O, Malecaze F, Alio J, Cochener B, Lobo C, Lazreg S, Hartani D, Colin J, Tassignon MJ, Behndig A; Intracameral Mydrane Study 2 Group. Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery. Br J Ophthalmol. 2016 Jul;100(7):976-985. doi: 10.1136/bjophthalmol-2015-307587. Epub 2015 Nov 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Phenylephrine | Small molecule | 10 % | — |
| Subject | T2380 | Unknown | 0.2 ml | Other |
| Comparator | tropicamide | Small molecule | 0.5 % | — |
| Background | tetracaine | Other / unclassified | 1 % | Topical |