drugset / Trial / NCT04087733
Effectiveness of Liposomial Ozonized-Oil for Cataract Surgery
Phase 4
Completed
200 enrolled
University of Molise
A.O.U. Città della Salute e della Scienza - Molinette Hospital · collabAzienda Ospedaliera Universitaria Mater Domini, Catanzaro · collabAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · collabAzienda Policlinico Umberto I, Roma · collabCasa di cura GEPOS, Telese · collabCentro Medico Oculistico ALSO, Saronno · collabCentro oftalmologico LASERVISTA, Caserta · collabClinica Mediterranea, Napoli · collabFondazione G.B. Bietti, IRCCS , Roma · collabOspedale G. Panico, Tricase · collabOspedale Policlinico Casilino, Roma · collabOspedale San Carlo di Nancy, Roma · collabOspedale Santa Croce-Carle Cuneo · collabOspedale generale regionale F. Miulli, Acquaviva delle Fonti · collabStudio oculistico Franchini · collabStudio oculistico Laborante · collabU.C.O Ospedali Civico di Cristina Benfratelli · collabUniversità degli Studi del Molise, Clinica Oculistica · collab
Non-randomizedParallel-groupOpen-labelOther
Summary
Evaluation of the antimicrobial efficacy of a liposomal ozone-based solution (OZODROP®) , vs placebo in 200 patients undergoing cataract surgery by phacoemulsification . The clinical trial will last 3 days of treatment per patient. The conjunctival swab will be taken for each of the two eyes (in treatment and control) at T0 (before starting the treatment - 3 days before the cataract surgery) and at T3 (after 3 days of treatment - immediately before the cataract surgery). The last OZODROP instillation will take place 10 minutes before taking the sample.
Timeline
- Start
- 2019-10-01
- Primary completion
- 2020-06-30
- Completion
- 2020-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OZODROP | Other / unclassified | 0.5 % | Other |