Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Liposomial Ozonized-Oil for Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087733
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Ospedale Oftalmico, Torino
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Policlinico San Matteo Pavia Fondazione IRCCS
Ospedale Policlinico San Martino
Ospedale Borgo Trento - Verona
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliero-Universitaria Careggi
University of Chieti
Azienda Policlinico Umberto I
S.Eugenio Hospital
Clinica Mediterranea
Information provided by (Responsible Party):
University of Molise

Brief 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.


Condition or disease Intervention/treatment Phase
Ocular Infections Drug: OZODROP Phase 4

Detailed Description:

The aim of the study is to assess the efficacy of a liposomal ozone-based solution (OZODROP®) in the preparation of the patient for cataract surgery, by evaluating the reduction of bacterial colonization of the conjunctiva.

The study will be carried out at 20 surgical centers located throughout the national territory and will be conducted in accordance with the recommendations of Italian ethics committees.

An informed consent will be provided to all study participants. 400 eyes of 200 patients undergoing cataract surgery by phacoemulsification will be included in the study. The clinical sample is divided into two groups, study group which will include treated and (GS) and control group (GC) eyes. The study group will be treated with OZODROP®, an isotonic ophthalmic solution composed of 0.5% ozonized oil in liposomes and hypromellose, while the GC will not be treated.

At the time of recruitment, all eyes will undergo a complete examination, as usual, and the patient enrolled in the study will be shown how to proceed.

The study includes 2 times, (T0) and (T3), equal for both groups in the study. 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 untreated contralateral eye 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. The reduction of conjunctival microbial flora, expressed as CFU, will be evaluated.

Through the analysis of the parameters in the study, a significant reduction in the microbial flora of the conjunctiva is expected in patients undergoing treatment with OZODROP®.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

GROUP / TREATED EYE (OZODROP® ): OZODROP® (ozonized oil 0.5% in liposomes) ophthalmic solution, 2 drops 4 times a day. OZODROP® will be instilled in the eye that will have to undergo cataract surgery.

GROUP / CONTROL EYE: No treatment. As a check you will use the contralateral eye that will not have to undergo cataract surgery.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of Liposomial Ozonized-Oil on Ocular Microbial Flora Before Cataract Surgery
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 3, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Ozone

Arm Intervention/treatment
Experimental: GROUP / TREATED EYE
OZODROP® (ozonized oil 0.5% in liposomes) ophthalmic solution, 2 drops 4 times a day. OZODROP® will be instilled in the eye that will have to undergo cataract surgery.
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 untreated contralateral eye 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
Other Name: liposomal ozone-based solution

No Intervention: GROUP / CONTROL EYE
No treatment. As a check it will be used the contralateral eye that will not have to undergo cataract surgery.



Primary Outcome Measures :
  1. Reduction of conjunctival bacterial load assessed by CFU (Colony Forming Units) using Ozodrop in 200 patients before cataract surgery [ Time Frame: 3 days ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087733


Contacts
Layout table for location contacts
Contact: Ciro Costagliola 08744092269 ciro.costagliola@unimol.it

Locations
Layout table for location information
Italy
University of Molise Recruiting
Campobasso, Italy
Contact: Costagliola Ciro    08744092269    ciro.costagliola@unimol.it   
Sponsors and Collaborators
University of Molise
Ospedale Oftalmico, Torino
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Policlinico San Matteo Pavia Fondazione IRCCS
Ospedale Policlinico San Martino
Ospedale Borgo Trento - Verona
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliero-Universitaria Careggi
University of Chieti
Azienda Policlinico Umberto I
S.Eugenio Hospital
Clinica Mediterranea
Investigators
Layout table for investigator information
Principal Investigator: Ciro Costagliola University of Molise

Additional Information:
Layout table for additonal information
Responsible Party: University of Molise
ClinicalTrials.gov Identifier: NCT04087733     History of Changes
Other Study ID Numbers: 0003-08-2018
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Eye Infections
Cataract
Lens Diseases
Eye Diseases
Infection