Bacterial ConjunctivitisPhase 4NCT00312338
Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora
A Phase 4 study testing VIGAMOX in people with Bacterial Conjunctivitis, run by Alcon Research at 1 site in United States.
Trial summary
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- VIGAMOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2007
- Phase
- Phase 4
- 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 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in either or both eyes (for < 3 days duration) based on clinical observation; matched healthy controls
Who cannot join
- Cannot have had bacterial conjunctivitis symptoms as reported by parent for > 2 days
Trial locations and contacts
1 site in 1 country.
About this study
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
- Conditions
- Bacterial Conjunctivitis
- Being tested
- VIGAMOX
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIGAMOXDrug
1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Infected Patient treated with Vigamox | Experimental | Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days. Receives: Drug: VIGAMOX |
| Healthy Subjects | No intervention | Healthy Subjects receiving no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation
Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).
0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Measured: Day 0 and Day 42
Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation
Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).
0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Measured: Day 0, Day 42
Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation
Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).
0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Measured: Day 0, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionJun 2007
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 Bacterial ConjunctivitisStudies 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 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts University
- Responsible party
- Sponsor
- Investigators
- Steven J. Lichtenstein, M.D., Principal investigator, Investigator / Contact
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312338
- Sponsor's protocol ID
- CMS-05-11
- Status last verified
- Feb 2010
- First submitted
- 4 Apr 2006
- Last updated
- 2 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora
- ClinicalTrials.gov ID
- NCT00312338
- Acronym / sponsor ID
- CMS-05-11
- Conditions
- Bacterial Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Tufts University
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Apr 2006 (estimated)
- Results
- Posted 2 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infected Patient treated with Vigamox | Experimental | Drug: VIGAMOXConjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days. |
| Healthy Subjects | No intervention | –Healthy Subjects receiving no treatment |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in either or both eyes (for < 3 days duration) based on clinical observation; matched healthy controls
Key exclusion criteria (1 listed)
- Cannot have had bacterial conjunctivitis symptoms as reported by parent for > 2 days
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 |
|---|---|---|
| VIGAMOX1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days | Drug | Infected Patient treated with Vigamox |
Primary outcome
Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation
Time frame: Day 0 and Day 42
Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation
Time frame: Day 0, Day 42
Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation
Time frame: Day 0, Day 42
Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven J. Lichtenstein, M.D. principal investigator
Investigator / Contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VIGAMOX in people with Bacterial Conjunctivitis, 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 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: finished, as of the sponsor's last update on 2 Nov 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 Feb 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?
Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation (time frame: Day 0 and Day 42). The study lists 3 primary outcomes in all. 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 Nov 2012.