Effectiveness of Liposomial Ozonized-Oil for Cataract Surgery

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.

Conditions

• Ocular Infections

Interventions

DRUG

OZODROP

3 days before the cataract surgery (T0), two conjunctival swabs will be taken from the patients enrolled in the study, one in the eye to be operated and one in the control eye, who will be kept at a controlled temperature (+ 2 / + 7 ° C) and sent to the laboratory within 24 hours. Than, starting on the day of collection, the patients will instill the OZODROP® eye drops in the eye to be used (2 drops 4 times a day, 1 drop every 4 hours: 9:00 am, 1:00 pm, 5:00 pm: 00, h21: 00), while the contralateral eye will be treated with a saline solution and it will serve as a control. Immediately before the cataract surgery (T3), the patients enrolled in the study will again receive two conjunctival swabs, one in the eye to be operated and one in the control eye. The last OZODROP® instillation will be carried out 10 minutes before the withdrawal. For the microbiological evaluation, the conjunctival swabs taken at T0 and T3 will be sent to the Microbiology laboratory

Sponsors & Collaborators

• Azienda Policlinico Umberto I, Roma

  collaborator UNKNOWN

• Università degli Studi del Molise, Clinica Oculistica

  collaborator UNKNOWN

• Clinica Mediterranea, Napoli

  collaborator UNKNOWN

• Ospedale Santa Croce-Carle Cuneo

  collaborator OTHER

• Centro Medico Oculistico ALSO, Saronno

  collaborator UNKNOWN

• Fondazione G.B. Bietti, IRCCS , Roma

  collaborator UNKNOWN

• Ospedale San Carlo di Nancy, Roma

  collaborator UNKNOWN

• Centro oftalmologico LASERVISTA, Caserta

  collaborator UNKNOWN

• Casa di cura GEPOS, Telese

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  collaborator OTHER

• Ospedale generale regionale F. Miulli, Acquaviva delle Fonti

  collaborator UNKNOWN

• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

  collaborator OTHER

• Ospedale Policlinico Casilino, Roma

  collaborator UNKNOWN

• Ospedale G. Panico, Tricase

  collaborator UNKNOWN

• Studio oculistico Laborante

  collaborator UNKNOWN

• Studio oculistico Franchini

  collaborator UNKNOWN

• U.C.O Ospedali Civico di Cristina Benfratelli

  collaborator UNKNOWN

• A.O.U. Città della Salute e della Scienza - Molinette Hospital

  collaborator OTHER

• University of Molise

  lead OTHER

Principal Investigators

• Ciro Costagliola · University of Molise

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2020-06-30

Completion

2020-09-30

Countries

• Italy

Study Locations