Acute Bacterial ConjunctivitisPhase 3NCT01227915
Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis
A Phase 3 study testing Tobracort and Tobradex in people with Acute Bacterial Conjunctivitis, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The primary objective of this study is to evaluate, through clinical parameters, the comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% - Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using the percentage of improvement (sustained response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bacterial Conjunctivitis
- What is being tested?
- Tobracort and Tobradex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Feb 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agree with all study procedures and sign, by his own free will, IC;
- Adult patients, regardless of gender, ethnicity or social status, with good mental health;
- Patients who present at screening visit, a clinical picture of acute bacterial conjunctivitis diagnosed clinically.
Who cannot join
- Patients with clinical diagnosis of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis;
- Patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars;
- Patients with known hypersensitivity to any component of the study drug;
- Concomitant use of ocular medication other than the study;
- Patients who have made use of systemic anti-inflammatory hormone in the 30 days preceding inclusion;
- Patients who have made use of systemic antibiotics in the 15 days preceding inclusion;
- Pregnant or lactating women;
- Being or having been treated for any type of conjunctivitis is less than 15 days, or have finished treatment at least 7 days
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo
Alexandre Frederico, doctor, 55 19 3871-6399, alexandre@lalclinica.com.br
Jose Roberto de Camargo, doctor
About this study
Official title: RANDOMIZED CLINICAL EVALUATION OF EFFECTIVENESS COMPARISON BETWEEN DRUGS OPHTHALMOLOGICAL TOBRACORT® (TOBRAMYCIN + DEXAMETHASONE - LAB. UNIÃO QUÍMICA)AND TOBRADEX® (TOBRAMYCIN + DEXAMETHASONE - LAB. ALCON) IN REDUCING THE SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
The primary objective of this study is to evaluate, through clinical parameters, the comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% - Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using the percentage of improvement (sustained response rate) at the end of treatment.
Read the detailed description
- Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter;
- Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
- Conditions
- Acute Bacterial Conjunctivitis
- Being tested
- Tobracort, Tobradex
- Keywords
- SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobracortDrug
tobramycin 0.3% + dexamethasone 1%
TobradexDrug
tobramycin 0.3% + dexamethasone 1%
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | tobramycin 0.3% + dexamethasone 1% - União Química Lab Receives: Drug: Tobracort |
| Comparator | Active comparator | tobramycin 0.3% + dexamethasone 1% - Alcon Lab Receives: Drug: Tobradex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.
There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
Measured: 7 days of treatment
Secondary outcomes (2)
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.
There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
Measured: 7 days of treatment.
Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
Measured: 7 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bacterial ConjunctivitisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227915
- Sponsor's protocol ID
- TODUNI0610
- Other IDs
- Version 01
- Status last verified
- Oct 2010
- First submitted
- 15 Oct 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED CLINICAL EVALUATION OF EFFECTIVENESS COMPARISON BETWEEN DRUGS OPHTHALMOLOGICAL TOBRACORT® (TOBRAMYCIN + DEXAMETHASONE - LAB. UNIÃO QUÍMICA)AND TOBRADEX® (TOBRAMYCIN + DEXAMETHASONE - LAB. ALCON) IN REDUCING THE SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
- ClinicalTrials.gov ID
- NCT01227915
- Acronym / sponsor ID
- TODUNI0610
- Conditions
- Acute Bacterial Conjunctivitis
- Keywords
- SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2011 (estimated)
- First posted
- 25 Oct 2010 (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 primary objective of this study is to evaluate, through clinical parameters, the comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% - Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using the percentage of improvement (sustained response rate) at the end of treatment.
Detailed description
- Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter;
- Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Tobracorttobramycin 0.3% + dexamethasone 1% - União Química Lab |
| Comparator | Active comparator | Drug: Tobradextobramycin 0.3% + dexamethasone 1% - Alcon Lab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who agree with all study procedures and sign, by his own free will, IC;
Key exclusion criteria (8 listed)
- Patients with clinical diagnosis of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis;
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 |
|---|---|---|
| Tobracorttobramycin 0.3% + dexamethasone 1% | Drug | Test |
| Tobradextobramycin 0.3% + dexamethasone 1% | Drug | Comparator |
Primary outcome
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.
Time frame: 7 days of treatment
There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
2 secondary outcomes
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.
Time frame: 7 days of treatment.
Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
Time frame: 7 days of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
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.
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, Brazil
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 Tobracort and Tobradex in people with Acute Bacterial Conjunctivitis, run by Azidus Brasil 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 3 inclusion and 8 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 25 Oct 2010. 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?
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?
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment. (time frame: 7 days of treatment). 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 25 Oct 2010.