AntisepticsNCT05974124
Effectiveness of Ophthalmic Antiseptic Preparations
A study testing Povidone-Iodine 0.66% and Chlorhexidine 0.02% in people with Antiseptics and Microbiota, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiseptics, Microbiota, Conjunctiva
- What is being tested?
- Povidone-Iodine 0.66% and Chlorhexidine 0.02%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 9 Nov 2022to 3 Feb 2023
- Phase
- Interventional
- 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
- Patients undergoing cataract surgery
- 18 years of age or older
Who cannot join
- Reported allergy or hypersensitivity to iodine or chlorhexidine
- Active ocular infection
- Contraindication to surgery
- Pregnant women
- Patients residing in nursing homes or prison
- Patients who used antibiotic, antiviral or antifungal eye drops in the week preceding the intervention
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
About this study
Official title: Topical Ophthalmic Antiseptics and Reduction of Ocular Surface Bacterial Load Before Cataract Surgery: a Randomized Clinical Trial
The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.
Read the detailed description
70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35 patients used PVI 0.66% 4 times daily starting 3 days before surgery; 35 patients used CHX 0.02% with the same posology. The contralateral eye was considered as control. Conjunctival swabs were collected in both eyes at the baseline (T0) and after three days of treatment (T1) all before cataract surgery. Conjunctival bacterial load has been evaluated through a molecular based method at T0 and T1 and compared to the control eye.
- Conditions
- Antiseptics, Microbiota, Conjunctiva
- Being tested
- Povidone-Iodine 0.66%, Chlorhexidine 0.02%
- Keywords
- Povidone-iodine, Chlorhexidine, Preoperative, Antiseptics, Conjunctival bacterial flora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-Iodine 0.66%Device
Povidone-iodine 0.66% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.
Chlorhexidine 0.02%Device
Chlorhexidine 0.02% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Povidone-Iodine 0.66% Receives: Device: Povidone-Iodine 0.66% |
| Group B | Experimental | Chlorhexidine 0.02% Receives: Device: Chlorhexidine 0.02% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival composition
Molecular based method: 16S rRNA gene was sequenced to evaluate ocular microbiota
Measured: 3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.
Secondary outcomes (2)
Patient pain score
Numerical rating scale, from 0 to 10
Measured: Day 3: after 3 days of treatment
Compliance of the patients
Questionnaire about patients' compliance
Measured: Day 3: after 3 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start9 Nov 2022
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntisepticsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomised to instill either povidone-iodine eye drops (35 patients) or chlorhexidine (35 patients) in the eye to be operated on. The contralateral eye was considered as control and received no antiseptic prophylaxis.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- European School of Advanced Studies in Ophthalmology
- Responsible party
- Principal investigator, Vito Romano, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Vito Romano, MD, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974124
- Sponsor's protocol ID
- OS1
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Ophthalmic Antiseptics and Reduction of Ocular Surface Bacterial Load Before Cataract Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05974124
- Acronym / sponsor ID
- OS1
- Conditions
- Antiseptics, Microbiota, Conjunctiva
- Keywords
- Povidone-iodine, Chlorhexidine, Preoperative, Antiseptics, Conjunctival bacterial flora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- European School of Advanced Studies in Ophthalmology
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 3 Aug 2023 (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.
The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.
Detailed description
70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35 patients used PVI 0.66% 4 times daily starting 3 days before surgery; 35 patients used CHX 0.02% with the same posology. The contralateral eye was considered as control. Conjunctival swabs were collected in both eyes at the baseline (T0) and after three days of treatment (T1) all before cataract surgery. Conjunctival bacterial load has been evaluated through a molecular based method at T0 and T1 and compared to the control eye.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomised to instill either povidone-iodine eye drops (35 patients) or chlorhexidine (35 patients) in the eye to be operated on. The contralateral eye was considered as control and received no antiseptic prophylaxis.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Povidone-Iodine 0.66%Povidone-Iodine 0.66% |
| Group B | Experimental | Device: Chlorhexidine 0.02%Chlorhexidine 0.02% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing cataract surgery
- 18 years of age or older
Key exclusion criteria (6 listed)
- Reported allergy or hypersensitivity to iodine or chlorhexidine
- Active ocular infection
- Contraindication to surgery
- Pregnant women
- Patients residing in nursing homes or prison
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 |
|---|---|---|
| Povidone-Iodine 0.66%Povidone-iodine 0.66% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment. | Device | Group A |
| Chlorhexidine 0.02%Chlorhexidine 0.02% eye drops were instilled 4 times daily for 3 days before cataract surgery in the eye to be operated on. The contralateral eye was considered as control and received no treatment. | Device | Group B |
Primary outcome
Conjunctival composition
Time frame: 3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.
Molecular based method: 16S rRNA gene was sequenced to evaluate ocular microbiota
2 secondary outcomes
Patient pain score
Time frame: Day 3: after 3 days of treatment
Compliance of the patients
Time frame: Day 3: after 3 days of treatment
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 4 Aug 2023.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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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.
Vito Romano, MD principal investigator
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine 0.66% and Chlorhexidine 0.02% in people with Antiseptics and Microbiota, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 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 2 inclusion and 6 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 4 Aug 2023. 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.
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?
Conjunctival composition (time frame: 3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.). 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 4 Aug 2023.