Ocular Inflammation Associated With BlepharaconjunctivitisPhase 3NCT00576251
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
A Phase 3 study testing Tobramycin 0.3%/Dexamethasone 0.05% and TOBRADEX in people with Ocular Inflammation Associated With Blepharaconjunctivitis, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Ocular Inflammation Associated With Blepharaconjunctivitis
- What is being tested?
- Tobramycin 0.3%/Dexamethasone 0.05% and TOBRADEX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ocular inflammation associated with blepharaconjunctivitis
Who cannot join
- ocular allergy
- ocular disorders that would preclude safe administration of test article
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis
- Being tested
- Tobramycin 0.3%/Dexamethasone 0.05%, TOBRADEX
- Keywords
- Ocular inflammation, blepharaconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin 0.3%/Dexamethasone 0.05%Drug
Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days
TOBRADEXDrug
TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05% | Experimental | Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes Receives: Drug: Tobramycin 0.3%/Dexamethasone 0.05% |
| TOBRADEX | Active comparator | TOBRADEX 1 drop 4 times daily in both eyes Receives: Drug: TOBRADEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
Measured: Day 4 - Test Of Cure (TOC) compared to Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular Inflammation Associated With BlepharaconjunctivitisStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Brubaker, BSN MPH, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576251
- Sponsor's protocol ID
- C-07-19
- Status last verified
- Feb 2010
- First submitted
- 17 Dec 2007
- Last updated
- 2 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
- ClinicalTrials.gov ID
- NCT00576251
- Acronym / sponsor ID
- C-07-19
- Keywords
- Ocular inflammation, blepharaconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008
- First posted
- 19 Dec 2007 (estimated)
- Results
- Posted 14 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05% | Experimental | Drug: Tobramycin 0.3%/Dexamethasone 0.05%Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes |
| TOBRADEX | Active comparator | Drug: TOBRADEXTOBRADEX 1 drop 4 times daily in both eyes |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Ocular inflammation associated with blepharaconjunctivitis
Key exclusion criteria (2 listed)
- ocular allergy
- ocular disorders that would preclude safe administration of test article
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 |
|---|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05%Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days | Drug | Tobramycin 0.3%/Dexamethasone 0.05% |
| TOBRADEXTOBRADEX 1 drop in both eyes 4 times daily for at least 3 days | Drug | TOBRADEX |
Primary outcome
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
Time frame: Day 4 - Test Of Cure (TOC) compared to Day 0
Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Michael Brubaker, BSN MPH study director
Alcon Research
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 Tobramycin 0.3%/Dexamethasone 0.05% and TOBRADEX in people with Ocular Inflammation Associated With Blepharaconjunctivitis, run by Alcon Research at 1 site in United States.
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 2 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 2 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) (time frame: Day 4 - Test Of Cure (TOC) compared to Day 0). 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 2 Mar 2010.