NCT04087733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

July 18, 2019

Last Update Submit

February 8, 2021

Conditions

Ocular Infections

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

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.

Interventions

OZODROPDRUG

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

Also known as: liposomal ozone-based solution
GROUP / TREATED EYE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Patients eligible for cataract surgery
  • Willingness to participate in the study following the indications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Molise

Campobasso, Italy

Location

Related Links

MeSH Terms

Conditions

Eye Infections

Condition Hierarchy (Ancestors)

InfectionsEye Diseases

Study Officials

  • Ciro Costagliola

    University of Molise

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2019

First Posted

September 12, 2019

Study Start

October 1, 2019

Primary Completion

June 30, 2020

Study Completion

September 30, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)