Effectiveness of Liposomial Ozonized-Oil for Cataract Surgery

University of Molise

Status and phase: Completed; Phase 4

Conditions: Ocular Infections

Treatments: Drug: OZODROP

Study type: Interventional

Funder types: Other

Identifiers

NCT04087733

0003-08-2018

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

GROUP / TREATED EYE

Experimental group

Description:

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.

Treatment:

Drug: OZODROP

GROUP / CONTROL EYE

No Intervention group

Description:

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.