Eye InfectionsPhase 4NCT01739920
Comparative Efficacy of Different Regimens of PVPI 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
A Phase 4 study testing Povidone-iodine and Saline Solution in people with Eye Infections, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI) eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any intraocular surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Infections
- What is being tested?
- Povidone-iodine and Saline Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Apr 2015
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No systemic or ocular infection;
- Absence of auto-imune disease or immunosuppressive therapy;
- No use of systemic or topic antibiotics in the last 30 days;
- No previous ocular surgery or trauma in the study eye in the last 30 days;
- No history of allergy to povidone iodine;
- Signed informed consent.
Who cannot join
- Presence of blepharitis, ectropion, entropion, trichiasis or distichiasis;
- Diabetes Mellitus;
- Any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza;
- Inability to understand and sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital of Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI) eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any intraocular surgical procedure.
Read the detailed description
Studies have demonstrated that the external bacterial flora of the patients in most cases is the actual source of infection. The objective of antisepsis is to eliminate or significantly reduce the number of microorganisms in the surgical field at the time of surgery. The eyelids and the conjunctiva are considered to be quite common sources of bacteria that can lead to endophthalmitis. Thus, it is believed that by reducing the number and growth of bacteria on the ocular surface and adnexa before surgery, the risk of postoperative infection would be lower. Povidone-iodine 5% eye drops has been used in preoperative cataract surgery to prevent endophthalmitis and is the standard prophylactic action in preventing postoperative endophthalmitis being widely compared with other antibiotic eye drops and their associations. The standard procedure of prophylaxis of postoperative endophthalmitis corresponds to applying a single drop of povidone-iodine 2min before any intraocular surgical procedure. However, few studies have assessed the effectiveness of povidone-iodine 5% eye drops using different dosing regimens to achieve the best bactericidal effect. The aim of this study is to investigate different dosages with respect to the use of povidone-iodine drops to optimize the effectiveness of the agent, ensuring the best exogenous endophthalmitis prophylaxis.
- Conditions
- Eye Infections
- Being tested
- Povidone-iodine, Saline Solution
- Keywords
- Povidone-Iodine, Ophthalmic Solutions, Endophthalmitis, Preoperative procedures
- Medical subject headings
- Eye Infections, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-iodineOther
Povidone iodine 5% drop will be instilled into conjunctival sac.
Saline SolutionOther
1 drop of saline solution 0.9% will be instilled into conjunctival sac.
| Study group | Role | What they receive |
|---|---|---|
| Povidone-iodine | Experimental | 1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period. Receives: Other: Povidone-iodine |
| Povidone-iodine and Saline Solution | Active comparator | 1 drop of saline solution 0.9% will be instilled at time zero and 20-minute. At 28-minute will be instilled 1 drop of Povidone-iodine 5%. Receives: Other: Povidone-iodine; Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of negative cultures after treatment in both groups
Conjunctival swab will be obtained five minutes before and 30 minutes after the first povidone iodine drop will be instilled into the conjunctival sac of study eye. Conjunctival swabs were incubated aerobically in enriched Thioglycolate liquid medium (meat broth) and in three solid culture media (Agar Chocolate, Trypticase Soy Agar with 5% sheep blood, and Agar Sabouraud).
Measured: At 30-minute study period, a conjunctival sac swab will be obtained
Secondary outcomes (1)
Difference in corneal thickness change between groups.
Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas).
Measured: At 35-minute study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startMay 2011
- Primary completionOct 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye InfectionsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Leticia Fernandes Barroso, University of Sao Paulo
- Investigators
- Rodrigo Jorge, MD, PhD, Principal investigator, University of Sao PauloLeticia F Barroso, MD, Principal investigator, Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739920
- Sponsor's protocol ID
- 2516/2010
- Other IDs
- 2010/17350-6
- Status last verified
- Jan 2017
- First submitted
- 28 Nov 2012
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Two Different Regimens of Povidone-iodine 5% Eye Drops Instillation in Reducing Conjunctival Bacterial Flora
- ClinicalTrials.gov ID
- NCT01739920
- Acronym / sponsor ID
- 2516/2010
- Conditions
- Eye Infections
- Keywords
- Povidone-Iodine, Ophthalmic Solutions, Endophthalmitis, Preoperative procedures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2011 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Dec 2012 (estimated)
- 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 present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI) eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any intraocular surgical procedure.
Detailed description
Studies have demonstrated that the external bacterial flora of the patients in most cases is the actual source of infection. The objective of antisepsis is to eliminate or significantly reduce the number of microorganisms in the surgical field at the time of surgery. The eyelids and the conjunctiva are considered to be quite common sources of bacteria that can lead to endophthalmitis. Thus, it is believed that by reducing the number and growth of bacteria on the ocular surface and adnexa before surgery, the risk of postoperative infection would be lower. Povidone-iodine 5% eye drops has been used in preoperative cataract surgery to prevent endophthalmitis and is the standard prophylactic action in preventing postoperative endophthalmitis being widely compared with other antibiotic eye drops and their associations. The standard procedure of prophylaxis of postoperative endophthalmitis corresponds to applying a single drop of povidone-iodine 2min before any intraocular surgical procedure. However, few studies have assessed the effectiveness of povidone-iodine 5% eye drops using different dosing regimens to achieve the best bactericidal effect. The aim of this study is to investigate different dosages with respect to the use of povidone-iodine drops to optimize the effectiveness of the agent, ensuring the best exogenous endophthalmitis prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone-iodine | Experimental | Other: Povidone-iodine1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period. |
| Povidone-iodine and Saline Solution | Active comparator | Other: Povidone-iodine, Other: Saline Solution1 drop of saline solution 0.9% will be instilled at time zero and 20-minute. At 28-minute will be instilled 1 drop of Povidone-iodine 5%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- No systemic or ocular infection;
- Absence of auto-imune disease or immunosuppressive therapy;
- No use of systemic or topic antibiotics in the last 30 days;
- No previous ocular surgery or trauma in the study eye in the last 30 days;
- No history of allergy to povidone iodine;
Key exclusion criteria (4 listed)
- Presence of blepharitis, ectropion, entropion, trichiasis or distichiasis;
- Diabetes Mellitus;
- Any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza;
- Inability to understand and sign the informed consent.
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-iodinePovidone iodine 5% drop will be instilled into conjunctival sac. | Other | Povidone-iodine, Povidone-iodine and Saline Solution |
| Saline Solution1 drop of saline solution 0.9% will be instilled into conjunctival sac. | Other | Povidone-iodine and Saline Solution |
Primary outcome
Proportion of negative cultures after treatment in both groups
Time frame: At 30-minute study period, a conjunctival sac swab will be obtained
Conjunctival swab will be obtained five minutes before and 30 minutes after the first povidone iodine drop will be instilled into the conjunctival sac of study eye. Conjunctival swabs were incubated aerobically in enriched Thioglycolate liquid medium (meat broth) and in three solid culture media (Agar Chocolate, Trypticase Soy Agar with 5% sheep blood, and Agar Sabouraud).
1 secondary outcome
Difference in corneal thickness change between groups.
Time frame: At 35-minute study period.
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 25 Jan 2017.
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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.
Rodrigo Jorge, MD, PhD principal investigator
University of Sao Paulo
Leticia F Barroso, MD principal investigator
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone-iodine and Saline Solution in people with Eye Infections, run by University of Sao Paulo at 1 site in Brazil.
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 6 inclusion and 4 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 25 Jan 2017. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of negative cultures after treatment in both groups (time frame: At 30-minute study period, a conjunctival sac swab will be obtained). 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 25 Jan 2017.