HealthyPhase 1NCT00905762
Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
A Phase 1 study testing Gatifloxacin, Moxifloxacin and Besifloxacin in people with Healthy, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gatifloxacin, Moxifloxacin and Besifloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Apr 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to avoid all disallowed medications for the appropriate washout periods.
- Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart.
Who cannot join
- Have a known allergy and/or sensitivity to the test articles or its components or any therapy associated with the trial.
- Monocular.
- Have previously participated in a conjunctival biopsy study.
- Be currently enrolled in an investigational drug or device study or have uses of an investigational drug or device within 30 days of entry into this study.
- have a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Rochester, New York, 14609
About this study
Official title: A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation
The purpose of this study is to assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Conjunctival biopsies will be performed at specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic suspension four times a day for 5 days.
- Conditions
- Healthy
- Being tested
- Gatifloxacin, Moxifloxacin, Besifloxacin
- Keywords
- pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GatifloxacinDrug
Gatifloxacin 0.3% one drop instilled into study eye at visit 2.
MoxifloxacinDrug
Moxifloxacin 0.5% one drop instilled into study eye at visit 2.
BesifloxacinDrug
Also called Besivance
Besifloxacin 0.6% one drop instilled into study eye at visit 2.
| Study group | Role | What they receive |
|---|---|---|
| Besifloxacin | Experimental | Besifloxacin one drop instilled into study eye. Receives: Drug: Besifloxacin |
| Gatifloxacin | Active comparator | Gatifloxacin one drop instilled into study eye. Receives: Drug: Gatifloxacin |
| Moxifloxacin | Active comparator | Moxifloxacin one drop instilled into study eye. Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.
Measured: Biopsies collected at specified time points from 15 minutes to 24 hours
Secondary outcomes (2)
Visual acuity
Measured: Day -14 through Day 6(+/-1)
Slit Lamp Biomicroscopy
Measured: Day -14 through Day 6 (+/-)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Comstock, OD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905762
- Sponsor's protocol ID
- 608
- Status last verified
- Dec 2011
- First submitted
- 3 Apr 2009
- 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
- A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation
- ClinicalTrials.gov ID
- NCT00905762
- Acronym / sponsor ID
- 608
- Conditions
- Healthy
- Keywords
- pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 May 2009 (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 assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Conjunctival biopsies will be performed at specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic suspension four times a day for 5 days.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Besifloxacin | Experimental | Drug: BesifloxacinBesifloxacin one drop instilled into study eye. |
| Gatifloxacin | Active comparator | Drug: GatifloxacinGatifloxacin one drop instilled into study eye. |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinMoxifloxacin one drop instilled into study eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing to avoid all disallowed medications for the appropriate washout periods.
- Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart.
Key exclusion criteria (5 listed)
- Have a known allergy and/or sensitivity to the test articles or its components or any therapy associated with the trial.
- Monocular.
- Have previously participated in a conjunctival biopsy study.
- Be currently enrolled in an investigational drug or device study or have uses of an investigational drug or device within 30 days of entry into this study.
- have a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the 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 |
|---|---|---|
| GatifloxacinGatifloxacin 0.3% one drop instilled into study eye at visit 2. | Drug | Gatifloxacin |
| MoxifloxacinMoxifloxacin 0.5% one drop instilled into study eye at visit 2. | Drug | Moxifloxacin |
| BesifloxacinAlso: BesivanceBesifloxacin 0.6% one drop instilled into study eye at visit 2. | Drug | Besifloxacin |
Primary outcome
Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.
Time frame: Biopsies collected at specified time points from 15 minutes to 24 hours
2 secondary outcomes
Visual acuity
Time frame: Day -14 through Day 6(+/-1)
Slit Lamp Biomicroscopy
Time frame: Day -14 through Day 6 (+/-)
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.
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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.
Timothy Comstock, OD study director
Bausch & Lomb Incorporated
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 Gatifloxacin, Moxifloxacin and Besifloxacin in people with Healthy, 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 2 inclusion and 5 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?
Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue. (time frame: Biopsies collected at specified time points from 15 minutes to 24 hours). 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.