EndophthalmitisPhase 2NCT02595359
Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
A Phase 2 study testing Moxifloxacin in people with Endophthalmitis, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- Moxifloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to 20 Jun 2018
- Phase
- Phase 2
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of visually significant cataract
Who cannot join
- Has known allergies to moxifloxacin
- Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason
- Has a known history of a condition which causes an immuno-compromised host state
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.
Read the detailed description
Although cataract surgery is generally considered a safe procedure resulting in a favourable visual outcome, surgical complications do occur. The most feared complication is postoperative endophthalmitis which is an infectious condition caused by micro-organisms introduced to the interior of the eye during or after the surgical procedure.
As endophthalmitis is an infection, it should be preventable by antibiotic treatment.
Prophylactic antibiotic treatment can be given as topical treatment preoperatively, or during surgery directly into the anterior chamber, or as a subconjunctival, or it can be given as topical treatment postoperatively.
The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.
- Conditions
- Endophthalmitis
- Being tested
- Moxifloxacin
- Keywords
- endophthalmitis, antibiotic therapy, cataract surgery, prevention
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Also called Vigamox
Moxifloxacin intracameral
| Study group | Role | What they receive |
|---|---|---|
| moxifloxacin intracameral | Experimental | moxifloxacin injection given at conclusion of cataract intervention Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial cell count
Measured: 6-month; 1 year; 2 years
Secondary outcomes (1)
endophthalmitis incidence
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJan 2013
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco
- Investigators
- Rodrigo Lira, Principal investigator, Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595359
- Sponsor's protocol ID
- 0001
- Status last verified
- Apr 2019
- First submitted
- 2 Nov 2015
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
- ClinicalTrials.gov ID
- NCT02595359
- Acronym / sponsor ID
- 0001
- Conditions
- Endophthalmitis
- Keywords
- endophthalmitis, antibiotic therapy, cataract surgery, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 3 Nov 2015 (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 aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.
Detailed description
Although cataract surgery is generally considered a safe procedure resulting in a favourable visual outcome, surgical complications do occur. The most feared complication is postoperative endophthalmitis which is an infectious condition caused by micro-organisms introduced to the interior of the eye during or after the surgical procedure.
As endophthalmitis is an infection, it should be preventable by antibiotic treatment.
Prophylactic antibiotic treatment can be given as topical treatment preoperatively, or during surgery directly into the anterior chamber, or as a subconjunctival, or it can be given as topical treatment postoperatively.
The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| moxifloxacin intracameral | Experimental | Drug: Moxifloxacinmoxifloxacin injection given at conclusion of cataract intervention |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of visually significant cataract
Key exclusion criteria (3 listed)
- Has known allergies to moxifloxacin
- Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason
- Has a known history of a condition which causes an immuno-compromised host state
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 |
|---|---|---|
| MoxifloxacinAlso: VigamoxMoxifloxacin intracameral | Drug | moxifloxacin intracameral |
Primary outcome
endothelial cell count
Time frame: 6-month; 1 year; 2 years
1 secondary outcome
endophthalmitis incidence
Time frame: 1 month
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 24 Apr 2019.
- Individual participant dataSharing planned: Undecided. undecided
Related trials for Endophthalmitis
Not yet recruiting
Vitrectomy Combined With Povidone-Iodine Vitreous Irrigation for Infectious Endophthalmitis
Endophthalmitis, Infectious Endophthalmitis
RecruitingObservational study
Nanopore Sequencing in Ophthalmology
Endophthalmitis
Not yet recruiting
Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
Cataract, Postoperative Endophthalmitis
RecruitingPhase 1
A Study of Ear Nerve Stimulation to Treat Eye Inflammation
Ocular Inflammation, Crystalline Lens; Chalcosis
Not yet recruitingPhase 2/3
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
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.
Rodrigo Lira principal investigator
Prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moxifloxacin in people with Endophthalmitis, run by Universidade Federal de Pernambuco 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 3 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 24 Apr 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
endothelial cell count (time frame: 6-month; 1 year; 2 years). 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 24 Apr 2019.