NCT04087733|CompletedPhase 4
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Sponsor study identifier
interventional
200
1 country
1
Study Start
October 1, 2019
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
September 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 18, 2019
Actual (reported)September 12, 2019
Actual (reported)October 1, 2019
Actual (reported)June 30, 2020
Actual (reported)September 30, 2020
Actual (reported)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
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.
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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Molise
Campobasso, Italy
Ciro Costagliola
University of Molise
200 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2019
First Posted
September 12, 2019
Study Start
Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations
Contact the study team to confirm eligibility.
October 1, 2019
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
September 30, 2020
Actual (reported)Last Updated
February 11, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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