Conjunctivitis, BacterialPhase 1NCT00407589
Systemic Pharmacokinetics of BOL-303224-A
A Phase 1 study testing BOL-303224-A in people with Conjunctivitis, Bacterial, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctivitis, Bacterial
- What is being tested?
- BOL-303224-A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 1
- 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
- must be at least 18 years of age, any race
- must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes
- women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test
Who cannot join
- Pregnant or nursing women
- known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication
- use of any antibiotic within 72 hours of enrollment
- participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornerstone Eyecare
High Point, North Carolina, 27262
About this study
Official title: Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis
This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.
- Conditions
- Conjunctivitis, Bacterial
- Being tested
- BOL-303224-A
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOL-303224-ADrug
Also called ISV-403, Besifloxacin
1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6).
| Study group | Role | What they receive |
|---|---|---|
| BOL-303224-A | Experimental | Systemic exposure of BOL-303224-A following single and multiple topical doses Receives: Drug: BOL-303224-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
Measured: Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5.
Secondary outcomes (1)
Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection
Measured: Througout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctivitis, BacterialStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407589
- Sponsor's protocol ID
- 478-PK
- Status last verified
- Dec 2011
- First submitted
- 1 Dec 2006
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis
- ClinicalTrials.gov ID
- NCT00407589
- Acronym / sponsor ID
- 478-PK
- Conditions
- Conjunctivitis, Bacterial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 5 Dec 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.
This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOL-303224-A | Experimental | Drug: BOL-303224-ASystemic exposure of BOL-303224-A following single and multiple topical doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- must be at least 18 years of age, any race
- must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes
- women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test
Key exclusion criteria (4 listed)
- Pregnant or nursing women
- known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication
- use of any antibiotic within 72 hours of enrollment
- participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study
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 |
|---|---|---|
| BOL-303224-AAlso: ISV-403, Besifloxacin1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6). | Drug | BOL-303224-A |
Primary outcome
Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
Time frame: Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5.
1 secondary outcome
Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection
Time frame: Througout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
Related trials for Conjunctivitis, Bacterial
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
RecruitingPhase 1/2
Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis
Bacterial Conjunctivitis
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
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 1 study testing BOL-303224-A in people with Conjunctivitis, Bacterial, run by Bausch & Lomb Incorporated 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 3 inclusion and 4 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 9 Dec 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing (time frame: Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5.). 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 9 Dec 2011.