EndophthalmitisPhase 2NCT05162625
Safety and Efficacy of Topical Moxifloxacin for Prevention of Post-Traumatic Endophthalmitis: Randomized Controlled Clinical Trial
A Phase 2 study testing Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution and Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV] in people with Endophthalmitis and Open Globe Injury, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Open globe injuries (OGI) are among the main causes of blindness or irreversible severe reduction in visual acuity in the world. An estimated 2.3 million people live with bilateral low vision and nearly 19 million live with blindness or unilateral low vision due to such trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis, Open Globe Injury, Moxifloxacin
- What is being tested?
- Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution and Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Dec 2021to 10 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open globe injury
Who cannot join
- Under 18 years old
- Requires intravenous antibiotics for other reasons
- Moxifloxacin allergy
- Imunossupressed patients
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Campinas
Campinas
Renata Diniz Lemos, MD
About this study
Open globe injuries (OGI) are among the main causes of blindness or irreversible severe reduction in visual acuity in the world. An estimated 2.3 million people live with bilateral low vision and nearly 19 million live with blindness or unilateral low vision due to such trauma. Pre-surgical prophylaxis to prevent serious infectious complications such as endophthalmitis is frequently performed, however, there are discrepancies in its performance between services as there is no proven superior protocol. Different combinations of antibiotics and administration routes are currently used.
The aim of this study is to evaluate the efficacy and safety of the use of topical moxifloxacin 0.5% ophthalmic solution (Vigamox®) in the prophylaxis of acute endophthalmitis in patients with OGI. This is a prospective, controlled, randomized, single-center study conducted in patients diagnosed with OGI at the Clinical Hospital of São Paulo State University, Campinas.
Read more
Volunteers who present OGI and sign the informed consent form (ICF) will be randomized into 2 groups: in group A, volunteers will undergo pre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery.
In group B, the volunteers will receive pre-surgical prophylaxis as it is currently done in the service, with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, prior to surgery. Intraoperative and post-surgical care will be the same for both groups and will continue to be carried out in line with the current service protocol. Patients will be followed for 45 days, with a complete ophthalmological evaluation that aims to verify the incidence of endophthalmitis in both groups. It is expected to find an equal or lower incidence of endophthalmitis in the group that received topical administration of moxifloxacin.
Read the detailed description
Patients diagnosed with OGI that requires surgery will be evaluated regarding visual acuity, biomicroscopy and fundoscopy, considering that the latter may not be possible in some cases due to the trauma severity. Those who, after being informed about all aspects of the surgery and this study, sign the ICF will be randomly divided into 2 groups of approximately equal sizes stratified by gender. Group A will receive, throughout the preoperative period, instillation of 0.5% moxifloxacin eye drops, 01 drop every 3 hours until the time of surgery. Group B will receive intravenous use of cefazolin 1 gram every 6 hours and ciprofloxacin 400mg every 12 hours.
The primary outcome is to evaluate the incidence of endophthalmitis in each group. The secondary outcome is to assess the other possible postoperative complications such as corneal decompensation and development of glaucoma and cataract, as well as analysis of the epidemiological profile of patients.
All patients will be hospitalized throughout the preoperative period, waiting for urgent surgery. All patients will remain with a non-compressive occlusive dressing during the preoperative period, being removed intraoperatively. The dressing will be removed and replaced only for the instillation of eye drops in patients allocated to group A. The surgery to correct OGI will be performed as already standardized in the Ophthalmology service at UNICAMP, by residents of the 3rd and 4th years, as well as assistant physicians and professors for cases of greater complexity and supervising all surgical procedures. The anesthetic technique will be performed according to the current protocol with general anesthesia. Skin antisepsis will be done with 10% aqueous povidone-iodine solution and then sterile surgical drapes will be placed with the eyelashes isolated.
The surgical technique will vary according to the trauma mechanism and the degree of ocular involvement, being defined by the preoperative surgical indication, but it may undergo changes according to the intraoperative evaluation.
Patients in both groups who present involvement of the lens and require its removal during surgery (facectomy) will receive an injection of 0.03ml of 0.5% moxifloxacin intracameral at the end of the surgery, as already standardized in the hospital. For the other cases, in which the lens is not affected, there will be no intracameral injection of 0.5% moxifloxacin.
All patients will receive instillation of 0.5% moxifloxacin eye drops associated with 0.1% dexamethasone (Vigadexa®) after the end of surgery and before the occlusive dressing. The postoperative prescription will consist of 0.5% moxifloxacin associated with 0.1% dexamethasone starting 3 hours after the end of the surgery, at a frequency of every 3 hours until the time the patient goes to sleep, for 7 days. After the 7th day Vigadexa® will be replaced by 0.1% dexamethasone without association with moxifloxacin and will be regressed weekly according to the inflammatory response of each individual.
Patients in both groups will not be masked as they will know if they are receiving eye drops or intravenous medication. Surgeons and ophthalmologists who will perform the exam in the postoperative period will not be masked.
In case of suspected endophthalmitis, an independent ophthalmologist of the retina and vitreous service will assess the patient, without knowing whether he belongs to group A or B, and will indicate the most appropriate procedure. The treatment of endophthalmitis will follow the hospital protocol. Postoperative consultations will take place on the 1st, 7th, 30th and 45th postoperative days with assessment of visual acuity (7th, 30th, 45th), refraction (30th), biomicroscopy (1st, 7th, 45th), tonometry of applanation (7th, 30th and 45th), keratometry (30th) funduscopy (30th and 45th), and endothelial cell count (45th). Occasionally, the performance of some of the aforementioned exams can be impaired by the ocular alteration resulting from OGI.
- Being tested
- Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution, Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV]
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin Ophthalmic 0.5% Ophthalmic SolutionDrug
Topical moxifloxacin 0,5% 01 drop every 3 hours
Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV]Drug
Also called + Cefazolin
Intravenous ciprofloxacin 400mg every 12 hours and cefazolin 1000mg every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Topical Moxifloxacin | Active comparator | Pre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery. Receives: Drug: Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution |
| Intravenous Cephazolin and Ciprofloxacin | Active comparator | Pre-surgical prophylaxis with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, until the surgery. Receives: Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that develop post-traumatic acute endophthalmitis in each group as assessed by a retina specialist according to clinical exam and ultrasonography findings
Post-traumatic endophthalmitis incidence rate in each group ( group A: topical moxifloxacin and group B: intravenous cefazolin plus ciprofloxacin)
Measured: Will be considered post-traumatic acute endophthalmitis if the patient evolve the condition until 45 days after open globe injury surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start10 Dec 2021 (estimated)
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Dec 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Violante Mélega, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162625
- Sponsor's protocol ID
- 52246021.8.0000.5404
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Topical Moxifloxacin for Prevention of Post-Traumatic Endophthalmitis: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05162625
- Acronym / sponsor ID
- 52246021.8.0000.5404
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 10 Dec 2021 (estimated)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 17 Dec 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.
Open globe injuries (OGI) are among the main causes of blindness or irreversible severe reduction in visual acuity in the world. An estimated 2.3 million people live with bilateral low vision and nearly 19 million live with blindness or unilateral low vision due to such trauma. Pre-surgical prophylaxis to prevent serious infectious complications such as endophthalmitis is frequently performed, however, there are discrepancies in its performance between services as there is no proven superior protocol. Different combinations of antibiotics and administration routes are currently used.
The aim of this study is to evaluate the efficacy and safety of the use of topical moxifloxacin 0.5% ophthalmic solution (Vigamox®) in the prophylaxis of acute endophthalmitis in patients with OGI. This is a prospective, controlled, randomized, single-center study conducted in patients diagnosed with OGI at the Clinical Hospital of São Paulo State University, Campinas.
Volunteers who present OGI and sign the informed consent form (ICF) will be randomized into 2 groups: in group A, volunteers will undergo pre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery.
In group B, the volunteers will receive pre-surgical prophylaxis as it is currently done in the service, with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, prior to surgery. Intraoperative and post-surgical care will be the same for both groups and will continue to be carried out in line with the current service protocol. Patients will be followed for 45 days, with a complete ophthalmological evaluation that aims to verify the incidence of endophthalmitis in both groups. It is expected to find an equal or lower incidence of endophthalmitis in the group that received topical administration of moxifloxacin.
Detailed description
Patients diagnosed with OGI that requires surgery will be evaluated regarding visual acuity, biomicroscopy and fundoscopy, considering that the latter may not be possible in some cases due to the trauma severity. Those who, after being informed about all aspects of the surgery and this study, sign the ICF will be randomly divided into 2 groups of approximately equal sizes stratified by gender. Group A will receive, throughout the preoperative period, instillation of 0.5% moxifloxacin eye drops, 01 drop every 3 hours until the time of surgery. Group B will receive intravenous use of cefazolin 1 gram every 6 hours and ciprofloxacin 400mg every 12 hours.
The primary outcome is to evaluate the incidence of endophthalmitis in each group. The secondary outcome is to assess the other possible postoperative complications such as corneal decompensation and development of glaucoma and cataract, as well as analysis of the epidemiological profile of patients.
All patients will be hospitalized throughout the preoperative period, waiting for urgent surgery. All patients will remain with a non-compressive occlusive dressing during the preoperative period, being removed intraoperatively. The dressing will be removed and replaced only for the instillation of eye drops in patients allocated to group A. The surgery to correct OGI will be performed as already standardized in the Ophthalmology service at UNICAMP, by residents of the 3rd and 4th years, as well as assistant physicians and professors for cases of greater complexity and supervising all surgical procedures. The anesthetic technique will be performed according to the current protocol with general anesthesia. Skin antisepsis will be done with 10% aqueous povidone-iodine solution and then sterile surgical drapes will be placed with the eyelashes isolated.
The surgical technique will vary according to the trauma mechanism and the degree of ocular involvement, being defined by the preoperative surgical indication, but it may undergo changes according to the intraoperative evaluation.
Patients in both groups who present involvement of the lens and require its removal during surgery (facectomy) will receive an injection of 0.03ml of 0.5% moxifloxacin intracameral at the end of the surgery, as already standardized in the hospital. For the other cases, in which the lens is not affected, there will be no intracameral injection of 0.5% moxifloxacin.
All patients will receive instillation of 0.5% moxifloxacin eye drops associated with 0.1% dexamethasone (Vigadexa®) after the end of surgery and before the occlusive dressing. The postoperative prescription will consist of 0.5% moxifloxacin associated with 0.1% dexamethasone starting 3 hours after the end of the surgery, at a frequency of every 3 hours until the time the patient goes to sleep, for 7 days. After the 7th day Vigadexa® will be replaced by 0.1% dexamethasone without association with moxifloxacin and will be regressed weekly according to the inflammatory response of each individual.
Patients in both groups will not be masked as they will know if they are receiving eye drops or intravenous medication. Surgeons and ophthalmologists who will perform the exam in the postoperative period will not be masked.
In case of suspected endophthalmitis, an independent ophthalmologist of the retina and vitreous service will assess the patient, without knowing whether he belongs to group A or B, and will indicate the most appropriate procedure. The treatment of endophthalmitis will follow the hospital protocol. Postoperative consultations will take place on the 1st, 7th, 30th and 45th postoperative days with assessment of visual acuity (7th, 30th, 45th), refraction (30th), biomicroscopy (1st, 7th, 45th), tonometry of applanation (7th, 30th and 45th), keratometry (30th) funduscopy (30th and 45th), and endothelial cell count (45th). Occasionally, the performance of some of the aforementioned exams can be impaired by the ocular alteration resulting from OGI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Moxifloxacin | Active comparator | Drug: Moxifloxacin Ophthalmic 0.5% Ophthalmic SolutionPre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery. |
| Intravenous Cephazolin and Ciprofloxacin | Active comparator | Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV]Pre-surgical prophylaxis with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, until the surgery. |
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 injury
Key exclusion criteria (5 listed)
- Under 18 years old
- Requires intravenous antibiotics for other reasons
- Moxifloxacin allergy
- Imunossupressed patients
- Pregnant women
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 Ophthalmic 0.5% Ophthalmic SolutionTopical moxifloxacin 0,5% 01 drop every 3 hours | Drug | Topical Moxifloxacin |
| Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV]Also: + CefazolinIntravenous ciprofloxacin 400mg every 12 hours and cefazolin 1000mg every 6 hours | Drug | Intravenous Cephazolin and Ciprofloxacin |
Primary outcome
Number of participants that develop post-traumatic acute endophthalmitis in each group as assessed by a retina specialist according to clinical exam and ultrasonography findings
Time frame: Will be considered post-traumatic acute endophthalmitis if the patient evolve the condition until 45 days after open globe injury surgery
Post-traumatic endophthalmitis incidence rate in each group ( group A: topical moxifloxacin and group B: intravenous cefazolin plus ciprofloxacin)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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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.
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 Ophthalmic 0.5% Ophthalmic Solution and Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV] in people with Endophthalmitis and Open Globe Injury, run by University of Campinas, Brazil 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 5 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 17 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata Diniz Lemos, MD (+55 (19) 993933379, rdinizlemos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that develop post-traumatic acute endophthalmitis in each group as assessed by a retina specialist according to clinical exam and ultrasonography findings (time frame: Will be considered post-traumatic acute endophthalmitis if the patient evolve the condition until 45 days after open globe injury surgery). 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 17 Dec 2021.