Effectiveness of Ophthalmic Antiseptic Preparations | NCT05974124

Studies
Effectiveness of Ophthalmic Antiseptic Preparations

NCT05974124

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status

Completed

Last Update Posted

Aug 4, 2023Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Antiseptics
Microbiota
Conjunctiva

Interventions

Povidone-Iodine 0.66%
Chlorhexidine 0.02%

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 9, 2022Actual

Primary Completion Date

Feb 3, 2023Actual

Completion Date

Feb 3, 2023Actual

First Submitted Date

Jul 26, 2023

First Submission Date that Met QC Criteria

Jul 26, 2023

First Posted Date

Aug 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2023

Last Update Posted Date

Aug 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vito Romano, Professor, Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaPrincipal Investigator

Lead Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaOTHER

Collaborators

Name	Class
European School of Advanced Studies in Ophthalmology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Povidone-Iodine 0.66%	Device: Povidone-Iodine 0.66%
Group B	Experimental	Chlorhexidine 0.02%	Device: Chlorhexidine 0.02%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conjunctival composition	Molecular based method: 16S rRNA gene was sequenced to evaluate ocular microbiota	3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.

Secondary Outcomes

Measure	Description	Time Frame
Patient pain score	Numerical rating scale, from 0 to 10	Day 3: after 3 days of treatment
Compliance of the patients	Questionnaire about patients' compliance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing cataract surgery
18 years of age or older

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vito Romano, MD	Università degli Studi di Brescia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia		Brescia		25123	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD that underlie results in a publication

Types

Study Protocol

Time Frame

After completion of the study

Access Criteria

Upon approval of individual sharing request

URL

Not provided

Intervention 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.