Eye InfectionsPhase 3NCT00335088
Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations
A Phase 3 study testing Moxifloxacin and Povidone Iodine vs Povidone Iodine in people with Eye Infections, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. Patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Eye Infections
- What is being tested?
- Moxifloxacin and Povidone Iodine vs Povidone Iodine
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to May 2007
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20 years.
- Various intraocular surgeries
Who cannot join
- Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Orly Halachmi, MD contact
Israel1 site, 1 recruiting
- Recruiting
Ophthalmology Department, HaEmek Medical Center, Afula, Israel
Afula, 18101
Orly Halachmi, MD, 972-4-6494344
Dan Miron, MD, 972-4-6494316, miron_da@yahoo.com
About this study
The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. Patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery.
Read the detailed description
Over all 500 patients admitted for various intraocular surgeries will be included in the study. The study will be prospective, double blind, placebo controlled, and randomized. Patients will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. For patients treated with povidone iodine alone a placebo will also be given. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery. All patients will be followed for 6 weeks for symptoms and signs of infection. Bacterial and fungal culture results will be compared between the 2 groups.
- Conditions
- Eye Infections
- Being tested
- Moxifloxacin and Povidone Iodine vs Povidone Iodine
- Keywords
- Prophylaxis,, Intraocular surgery, Lacrimal sac, Eye lid, No conditions
- Medical subject headings
- Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin and Povidone Iodine vs Povidone IodineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Type and amount of bacterial growth
Post surgery infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJun 2006
- Study completionMay 2007 (estimated)
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Dan Miron, MD, Study director, HaEmek Medicak Center, Afula, IsraelOrky Halachmi, MD, Principal investigator, HaEmek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335088
- Sponsor's protocol ID
- 4780506
- Status last verified
- Mar 2007
- First submitted
- 5 Jun 2006
- Last updated
- 1 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations
- ClinicalTrials.gov ID
- NCT00335088
- Acronym / sponsor ID
- 4780506
- Conditions
- Eye Infections
- Keywords
- Prophylaxis,, Intraocular surgery, Lacrimal sac, Eye lid, No conditions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- May 2007 (estimated)
- First posted
- 8 Jun 2006 (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 hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. Patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery.
Detailed description
Over all 500 patients admitted for various intraocular surgeries will be included in the study. The study will be prospective, double blind, placebo controlled, and randomized. Patients will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. For patients treated with povidone iodine alone a placebo will also be given. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery. All patients will be followed for 6 weeks for symptoms and signs of infection. Bacterial and fungal culture results will be compared between the 2 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 20 years.
- Various intraocular surgeries
Key exclusion criteria (1 listed)
- Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.
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 |
|---|---|---|
| Moxifloxacin and Povidone Iodine vs Povidone Iodine | Drug | – |
Primary outcome
Type and amount of bacterial growth
Post surgery infections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2007.
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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.
Orly Halachmi, MD contact
Dan Miron, MD study director
HaEmek Medicak Center, Afula, Israel
Orky Halachmi, MD principal investigator
HaEmek Medical Center, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxifloxacin and Povidone Iodine vs Povidone Iodine in people with Eye Infections, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 2007. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orly Halachmi, MD (972-4-649344), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type and amount of bacterial growth. The study lists 2 primary outcomes in all. 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 1 Jun 2007.