BlepharitisPhase 3BRA-07-02NCT00732446
Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis
A Phase 3 study testing Moxifloxacin and Dexamethasone combined, Moxifloxacin and Dexamethasone in people with Blepharitis and Conjunctivitis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Safety and efficacy of antibiotic steroid combination compared with individual administration in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis and/or conjunctivitis). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blepharitis, Conjunctivitis, Keratitis
- What is being tested?
- Moxifloxacin and Dexamethasone combined, Moxifloxacin and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Feb 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of blepharitis and/or keratitis and/or bacterial conjunctivitis
Who cannot join
- Uncontrolled glaucoma or intraocular hypertension
- Wear contact lens during the study
- Patients with sight in a single eye
- Suspicious of viral, fungic infection
- Use of any other ophthalmic drugs during the study
- Use of immunosuppressant therapy
- Known or suspected allergy or hypersensibility to any component of study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Safety and Efficacy of the Administration of a Fixed Combination of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops Compared With the Individual Administration of Moxifloxacin 0.5% and Dexamethasone 0.1% in the Treatment of Bacterial Ocular Inflammation and Infection (Blepharitis and/or Keratitis and/or Conjunctivitis)
Safety and efficacy of antibiotic steroid combination compared with individual administration in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis and/or conjunctivitis).
Read the detailed description
Antibiotic/steroid combination compared to individuals components 8 days of treatment.
- Conditions
- Blepharitis, Conjunctivitis, Keratitis
- Being tested
- Moxifloxacin and Dexamethasone combined, Moxifloxacin, Dexamethasone
- Keywords
- moxifloxacin, dexamethasone, ocular inflammation, ocular infection
- Medical subject headings
- Blepharitis, Conjunctivitis, Keratitis, Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin and Dexamethasone combinedDrug
Also called vigadexa
moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined
MoxifloxacinDrug
Also called maxidex and vigamox
moxifloxacin 0,5% qid and
DexamethasoneDrug
dexamethasone 0,1% qid
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | antibiotic /steroid combination compared with individual administration of steroid and antibiotic Receives: Drug: Moxifloxacin; Drug: Dexamethasone |
| 1 | Experimental | combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication Receives: Drug: Moxifloxacin and Dexamethasone combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)
Measured: Day 8
Secondary outcomes (1)
Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Rubens Belfort, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732446
- Sponsor's protocol ID
- BRA-07-02
- Acronym
- BRA-07-02
- Status last verified
- Aug 2008
- First submitted
- 11 Aug 2008
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Efficacy of the Administration of a Fixed Combination of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops Compared With the Individual Administration of Moxifloxacin 0.5% and Dexamethasone 0.1% in the Treatment of Bacterial Ocular Inflammation and Infection (Blepharitis and/or Keratitis and/or Conjunctivitis)
- ClinicalTrials.gov ID
- NCT00732446
- Acronym / sponsor ID
- BRA-07-02 / BRA-07-02
- Conditions
- Blepharitis, Conjunctivitis, Keratitis
- Keywords
- moxifloxacin, dexamethasone, ocular inflammation, ocular infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 12 Aug 2008 (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.
Safety and efficacy of antibiotic steroid combination compared with individual administration in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis and/or conjunctivitis).
Detailed description
Antibiotic/steroid combination compared to individuals components 8 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: Moxifloxacin, Drug: Dexamethasoneantibiotic /steroid combination compared with individual administration of steroid and antibiotic |
| 1 | Experimental | Drug: Moxifloxacin and Dexamethasone combinedcombination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diagnosis of blepharitis and/or keratitis and/or bacterial conjunctivitis
Key exclusion criteria (7 listed)
- Uncontrolled glaucoma or intraocular hypertension
- Wear contact lens during the study
- Patients with sight in a single eye
- Suspicious of viral, fungic infection
- Use of any other ophthalmic drugs during the study
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 Dexamethasone combinedAlso: vigadexamoxifloxacin 0,5% qid and dexamethasone 0,1% qid combined | Drug | 1 |
| MoxifloxacinAlso: maxidex and vigamoxmoxifloxacin 0,5% qid and | Drug | 2 |
| Dexamethasonedexamethasone 0,1% qid | Drug | 2 |
Primary outcome
Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)
Time frame: Day 8
1 secondary outcome
Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis
Time frame: Day 8
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 22 Jun 2011.
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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.
Rubens Belfort, MD principal investigator
Federal University of São Paulo
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 Dexamethasone combined, Moxifloxacin and Dexamethasone in people with Blepharitis and Conjunctivitis, 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 7 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 22 Jun 2011. 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 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?
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?
Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8) (time frame: Day 8). 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 22 Jun 2011.