Ocular Infections Clinical Trial
Official title:
Effectiveness of Liposomial Ozonized-Oil on Ocular Microbial Flora Before Cataract Surgery
Verified date | February 2021 |
Source | University of Molise |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age over 18 years 2. Patients eligible for cataract surgery 3. Willingness to participate in the study following the indications Exclusion Criteria: 1. Use of topical and / or systemic antibiotics and other topical antiseptics during the study 2. Presence of topical ocular therapies that cannot be suspended for the entire duration of the study 3. Ongoing ocular or systemic inflammatory or infectious processes 4. Hypersensitivity to the constituents of the preparation in study |
Country | Name | City | State |
---|---|---|---|
Italy | University of Molise | Campobasso |
Lead Sponsor | Collaborator |
---|---|
University of Molise | A.O.U. Città della Salute e della Scienza - Molinette Hospital, Azienda Ospedaliera Policlinico Mater Domini, Catanzaro, Azienda Ospedaliero-Universitaria Consorziale, Bari, Azienda Policlinico Umberto I, Roma, Casa di cura GEPOS, Telese, Centro Medico Oculistico ALSO, Saronno, Centro oftalmologico LASERVISTA, Caserta, Clinica Mediterranea, Napoli, Fondazione G.B. Bietti, IRCCS , Roma, Ospedale G. Panico, Tricase, Ospedale generale regionale F. Miulli, Acquaviva delle Fonti, Ospedale Policlinico Casilino, Roma, Ospedale San Carlo di Nancy, Roma, Ospedale Santa Croce-Carle Cuneo, Studio oculistico Franchini, Studio oculistico Laborante, U.C.O Ospedali Civico di Cristina Benfratelli, Università degli Studi del Molise, Clinica Oculistica |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of conjunctival bacterial load assessed by CFU (Colony Forming Units) using Ozodrop in 200 patients before cataract surgery | Reduction/eradication of conjunctival bacterial load in patients treated with ozodrop for three days before undergoing cataract surgery.
For the microbiological evaluation, the conjunctival swabs taken at T0 (before starting OZODROP instillation) and T3 (after instilling OZODROP 4 times/day for three days) will be sent to the Microbiology laboratory to be seeded, enriched and then isolated the different species under examination by suitable selective media. The different samples will be analyzed according to the routine methods used in microbiology. The untreated contralateral eye will serve as a control. |
3 days |