Ocular InfectionsPhase 4NCT04087733
Effectiveness of Liposomial Ozonized-Oil for Cataract Surgery
A Phase 4 study testing OZODROP in people with Ocular Infections, run by University of Molise at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Infections
- What is being tested?
- OZODROP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 30 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Patients eligible for cataract surgery
- Willingness to participate in the study following the indications
Who cannot join
- Use of topical and / or systemic antibiotics and other topical antiseptics during the study
- Presence of topical ocular therapies that cannot be suspended for the entire duration of the study
- Ongoing ocular or systemic inflammatory or infectious processes
- Hypersensitivity to the constituents of the preparation in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Liposomial Ozonized-Oil on Ocular Microbial Flora Before Cataract Surgery
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.
Read the 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 18 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 receive saline solution.
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®.
- Conditions
- Ocular Infections
- Being tested
- OZODROP
- Medical subject headings
- Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OZODROPDrug
Also called liposomal ozone-based solution
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
| Study group | Role | What they receive |
|---|---|---|
| GROUP / TREATED EYE | Experimental | 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. Receives: Drug: OZODROP |
| GROUP / CONTROL EYE | No intervention | Saline solution 2 drops 4 times a day. As a check it will be used the contralateral eye that will not have to undergo cataract surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Oct 2019
- Primary completion30 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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: saline solution 2 drops 4 times a day. As a check it will be used the contralateral eye that will not have to undergo cataract surgery.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, Università degli Studi del Molise, Clinica Oculistica, Clinica Mediterranea, Napoli, Ospedale Santa Croce-Carle Cuneo, Centro Medico Oculistico ALSO, Saronno, Fondazione G.B. Bietti, IRCCS , Roma, Ospedale San Carlo di Nancy, Roma, Centro oftalmologico LASERVISTA, Caserta, Casa di cura GEPOS, Telese, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Ospedale generale regionale F. Miulli, Acquaviva delle Fonti, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro, Ospedale Policlinico Casilino, Roma, Ospedale G. Panico, Tricase, Studio oculistico Laborante, Studio oculistico Franchini, U.C.O Ospedali Civico di Cristina Benfratelli, A.O.U. Città della Salute e della Scienza - Molinette Hospital
- Responsible party
- Sponsor
- Investigators
- Ciro Costagliola, Principal investigator, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087733
- Sponsor's protocol ID
- 0003-08-2018
- Status last verified
- Feb 2021
- First submitted
- 18 Jul 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Liposomial Ozonized-Oil on Ocular Microbial Flora Before Cataract Surgery
- ClinicalTrials.gov ID
- NCT04087733
- Acronym / sponsor ID
- 0003-08-2018
- Conditions
- Ocular Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, Università degli Studi del Molise, Clinica Oculistica, Clinica Mediterranea, Napoli, Ospedale Santa Croce-Carle Cuneo, Centro Medico Oculistico ALSO, Saronno, Fondazione G.B. Bietti, IRCCS , Roma, Ospedale San Carlo di Nancy, Roma, Centro oftalmologico LASERVISTA, Caserta, Casa di cura GEPOS, Telese, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Ospedale generale regionale F. Miulli, Acquaviva delle Fonti, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro, Ospedale Policlinico Casilino, Roma, Ospedale G. Panico, Tricase, Studio oculistico Laborante, Studio oculistico Franchini, U.C.O Ospedali Civico di Cristina Benfratelli, A.O.U. Città della Salute e della Scienza - Molinette Hospital
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 18 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 receive saline solution.
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®.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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: saline solution 2 drops 4 times a day. As a check it will be used the contralateral eye that will not have to undergo cataract surgery.
| Arm | Type | Receives |
|---|---|---|
| GROUP / TREATED EYE | Experimental | Drug: OZODROPOZODROP® (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 intervention | –Saline solution 2 drops 4 times a day. As a check it will be used the contralateral eye that will not have to undergo cataract surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Patients eligible for cataract surgery
- Willingness to participate in the study following the indications
Key exclusion criteria (4 listed)
- Use of topical and / or systemic antibiotics and other topical antiseptics during the study
- Presence of topical ocular therapies that cannot be suspended for the entire duration of the study
- Ongoing ocular or systemic inflammatory or infectious processes
- Hypersensitivity to the constituents of the preparation in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OZODROPAlso: liposomal ozone-based solution3 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 | Drug | GROUP / TREATED EYE |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Reduction in bacterial load using hypochlorous acid hygiene solution on ocular skin.Link provided by the sponsor.
- Human Microbiota and Ophthalmic Disease.Link provided by the sponsor.
- Aqueous chlorhexidine (0.1%) is an effective alternative to povidone-iodine for intravitreal injection prophylaxisLink provided by the sponsor.
- escrs guidelinesLink provided by the sponsor.
- Reduction of anterior chamber contamination rate after cataract surgery by intraoperative surface irrigation with 0.25% povidone-iodine.Link provided by the sponsor.
- Sub-Conjunctival Injection of Antibiotics vs. Povidone-Iodine Drop on Bacterial Colonies in Phacoemulsification Cataract Surgery.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciro Costagliola principal investigator
University of Molise
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OZODROP in people with Ocular Infections, run by University of Molise at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of conjunctival bacterial load assessed by CFU (Colony Forming Units) using Ozodrop in 200 patients before cataract surgery (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.