Bacterial ConjunctivitisPhase 4NCT00798577
Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment
A Phase 4 study testing Vigamox Ophthalmic Solution in people with Bacterial Conjunctivitis, run by Alcon Research at 1 site in United States.
Trial summary
The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- Vigamox Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2009
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis in one or both eyes of bacterial conjunctivitis based on:
- symptoms less than or equal to 24 hours prior to first visit
- rating > or equal to 1 for bulbar conjunctival injection
- must have a rating > 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at Visit 1, and
- Must experience some matting in the affected eye(s).
- 1 year of age or older, of any race and either sex
- Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation.
- Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance.
Who cannot join
- Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for > 24 hours.
- Any current lid disease on clinical examination.
- Known or suspected allergy or hypersensitivity to fluoroquinolones.
- Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
- Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency).
- Use of topical ocular medications during the study period.
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- Antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study.
- Women of childbearing potential not using reliable means of birth control.
- Women who are pregnant or lactating.
- Enrollment of more than one person per household at the same time.
- Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
- Participation in any investigational drug or device study within 30 days of entering this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134
About this study
The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.
- Conditions
- Bacterial Conjunctivitis
- Being tested
- Vigamox Ophthalmic Solution, BSS placebo
- Keywords
- Bacterial Conjunctivitis
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigamox Ophthalmic SolutionDrug
Moxifloxacin 5mg/mL 3 times daily for 7 days
BSS placeboDrug
Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Vigamox | Experimental | Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL) Receives: Drug: Vigamox Ophthalmic Solution |
| BSS Placebo | Placebo comparator | Balanced Salt Solution Receives: Drug: BSS placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory Outcomes From Digital Photography
Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.
Measured: 24 hours after administration of first dose
Secondary outcomes (4)
Exploratory Evaluation of Changes in Ocular Signs and Symptoms
Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis:
Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale.
Measured: Baseline (Day 1) to Day 2
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Measured: 24 hours after administration of first dose
Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Measured: 24 hour after administration of first dose
Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Measured: 24 hours after administration of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Topical Solutions Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798577
- Sponsor's protocol ID
- SMA-08-03
- Status last verified
- Mar 2010
- First submitted
- 25 Nov 2008
- Last updated
- 31 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 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT00798577
- Acronym / sponsor ID
- SMA-08-03
- Conditions
- Bacterial Conjunctivitis
- Keywords
- Bacterial Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Topical Solutions Ltd.
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 31 Mar 2010
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 investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vigamox | Experimental | Drug: Vigamox Ophthalmic SolutionVigamox Ophthalmic Solution (Moxifloxacin 5mg/mL) |
| BSS Placebo | Placebo comparator | Drug: BSS placeboBalanced Salt Solution |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis in one or both eyes of bacterial conjunctivitis based on:
- Must experience some matting in the affected eye(s).
- 1 year of age or older, of any race and either sex
- Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation.
- Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance.
Key exclusion criteria (12 listed)
- Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for > 24 hours.
- Any current lid disease on clinical examination.
- Known or suspected allergy or hypersensitivity to fluoroquinolones.
- Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
- Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency).
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 |
|---|---|---|
| Vigamox Ophthalmic SolutionMoxifloxacin 5mg/mL 3 times daily for 7 days | Drug | Vigamox |
| BSS placeboBalanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days | Drug | BSS Placebo |
Primary outcome
Exploratory Outcomes From Digital Photography
Time frame: 24 hours after administration of first dose
Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.
4 secondary outcomes
Exploratory Evaluation of Changes in Ocular Signs and Symptoms
Time frame: Baseline (Day 1) to Day 2
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
Time frame: 24 hours after administration of first dose
Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like
Time frame: 24 hour after administration of first dose
Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae
Time frame: 24 hours after administration of first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2010.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ophthalmic Solution 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 8 inclusion and 12 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 31 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. Some participants in this study may receive a placebo. 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 31 Mar 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?
Exploratory Outcomes From Digital Photography (time frame: 24 hours after administration of first dose). 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 31 Mar 2010.