EndophthalmitisPhase 4NCT05079854
Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
A Phase 4 study testing Intraocular Instillation Solution and Moxifloxacin Ophthalmic in people with Endophthalmitis and Trauma, Corneal, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Endophthalmitis is a severe inflammatory eye condition with profound impairment of vision, which can lead to irreversible visual loss and requires immediate treatment. There is no way to completely prevent endophthalmitis, however, through prophylactic methods, it is possible to reduce its incidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis, Trauma, Corneal
- What is being tested?
- Intraocular Instillation Solution and Moxifloxacin Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2021to 1 Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- open globe trauma
Who cannot join
- endophthalmitis at the beginning
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, São Paulo, 04023-062
Vinicius Campos Bergamo, MD, (11) 9 80589798, viniciusbergamo.epm@gmail.com
Mauricio Maia, MD, PhD, 5511-5572-6443, maiamauricio@terra.com.br
About this study
Endophthalmitis is a severe inflammatory eye condition with profound impairment of vision, which can lead to irreversible visual loss and requires immediate treatment.
There is no way to completely prevent endophthalmitis, however, through prophylactic methods, it is possible to reduce its incidence. Currently, the only technique that has reached category II of evidence in reducing the risks of endophthalmitis is the use of 5% povidone-iodine eye drops, moments before surgery. In 2007, the European Society of Cataract and Refractive Surgery (ESCRS) released a large multicenter randomized clinical trial, with data on the reduction in the rates of endophthalmitis, using the intracameral antibiotic therapy technique of perioperative cefuroxime. However, much is discussed about the risks related to the technique, such as dilutional errors, contamination, anaphylaxis and cost-effectiveness, which still makes the conduct debatable.
The study evaluates the use of intracameral Moxifloxacin 0.5% (Vigamox®) as prophylaxis in cases of endophthalmitis after open ocular trauma;
- Conditions
- Endophthalmitis, Trauma, Corneal
- Being tested
- Intraocular Instillation Solution, Moxifloxacin Ophthalmic
- Medical subject headings
- Endophthalmitis, Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular Instillation SolutionDrug
Also called Intracameral
Intracameral Moxifloxacin 0.5%
Moxifloxacin OphthalmicDrug
Topical Moxifloxacin 0.5%
| Study group | Role | What they receive |
|---|---|---|
| INTRACAMERAL MOXIFLOXACIN | Active comparator | After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL. Receives: Drug: Intraocular Instillation Solution |
| TOPICAL MOXIFLOXACIN | Active comparator | After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL. Receives: Drug: Moxifloxacin Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endophthalmitis
Evaluate the incidence of Endophthalmitis
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Oct 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio Maia, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079854
- Sponsor's protocol ID
- TOP_VIGAMOX
- Status last verified
- Nov 2021
- First submitted
- 3 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
- ClinicalTrials.gov ID
- NCT05079854
- Acronym / sponsor ID
- TOP_VIGAMOX
- Conditions
- Endophthalmitis, Trauma, Corneal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 15 Oct 2021 (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.
Endophthalmitis is a severe inflammatory eye condition with profound impairment of vision, which can lead to irreversible visual loss and requires immediate treatment.
There is no way to completely prevent endophthalmitis, however, through prophylactic methods, it is possible to reduce its incidence. Currently, the only technique that has reached category II of evidence in reducing the risks of endophthalmitis is the use of 5% povidone-iodine eye drops, moments before surgery. In 2007, the European Society of Cataract and Refractive Surgery (ESCRS) released a large multicenter randomized clinical trial, with data on the reduction in the rates of endophthalmitis, using the intracameral antibiotic therapy technique of perioperative cefuroxime. However, much is discussed about the risks related to the technique, such as dilutional errors, contamination, anaphylaxis and cost-effectiveness, which still makes the conduct debatable.
The study evaluates the use of intracameral Moxifloxacin 0.5% (Vigamox®) as prophylaxis in cases of endophthalmitis after open ocular trauma;
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTRACAMERAL MOXIFLOXACIN | Active comparator | Drug: Intraocular Instillation SolutionAfter the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL. |
| TOPICAL MOXIFLOXACIN | Active comparator | Drug: Moxifloxacin OphthalmicAfter the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- open globe trauma
Key exclusion criteria (1 listed)
- endophthalmitis at the beginning
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 |
|---|---|---|
| Intraocular Instillation SolutionAlso: IntracameralIntracameral Moxifloxacin 0.5% | Drug | INTRACAMERAL MOXIFLOXACIN |
| Moxifloxacin OphthalmicTopical Moxifloxacin 0.5% | Drug | TOPICAL MOXIFLOXACIN |
Primary outcome
Endophthalmitis
Time frame: 90 days
Evaluate the incidence of Endophthalmitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: Yes
Related trials for Endophthalmitis
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Nanopore Sequencing in Ophthalmology
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Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
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A Study of Ear Nerve Stimulation to Treat Eye Inflammation
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Endophthalmitis
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.
Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, Brazil
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 Intraocular Instillation Solution and Moxifloxacin Ophthalmic in people with Endophthalmitis and Trauma, Corneal, run by Federal University of São 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 1 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 10 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endophthalmitis (time frame: 90 days). 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 10 Nov 2021.