Post-surgical InflammationPhase 3NCT00404937
Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
A Phase 3 study testing Tobradex (Antibiotic steroid combination) in people with Post-surgical Inflammation, run by Alcon Research.
Trial summary
The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-surgical Inflammation
- What is being tested?
- Tobradex (Antibiotic steroid combination)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2006
- 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 scheduled for cataract extraction
Who cannot join
- Under 18 years
About this study
The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
- Conditions
- Post-surgical Inflammation
- Being tested
- Tobradex (Antibiotic steroid combination)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobradex (Antibiotic steroid combination)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber inflammation
Secondary outcomes (4)
Aqueous cells and flare
ocular pain
physician's impression of infection
frequency of treatment failures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgical InflammationStudies 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
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404937
- Sponsor's protocol ID
- C-05-60
- Status last verified
- Sep 2007
- First submitted
- 28 Nov 2006
- Last updated
- 6 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
- ClinicalTrials.gov ID
- NCT00404937
- Acronym / sponsor ID
- C-05-60
- Conditions
- Post-surgical Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 29 Nov 2006 (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 purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for cataract extraction
Key exclusion criteria (1 listed)
- Under 18 years
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 |
|---|---|---|
| Tobradex (Antibiotic steroid combination) | Drug | – |
Primary outcome
Anterior chamber inflammation
4 secondary outcomes
Aqueous cells and flare
ocular pain
physician's impression of infection
frequency of treatment failures
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobradex (Antibiotic steroid combination) in people with Post-surgical Inflammation, run by Alcon Research.
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 1 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: withdrawn, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Anterior chamber inflammation. 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 6 Mar 2012.