HealthyPhase 4NCT00703313
Ocular Availability in Human Tears After Topical Administration of 1.5% Levofloxacin Compared to Active Comparators
A Phase 4 study testing 1.5% levofloxacin ophthalmic solution, 0.5% moxifloxacin hydrochloride ophthalmic solution and 0.3% gatifloxacin ophthalmic solution in people with Healthy, run by Santen Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to compare the concentration in human tears of levofloxacin and the active comparators at 15 minutes, 2,6, 12, and 24 hours after instillation of a single drop of medication. 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?
- 1.5% levofloxacin ophthalmic solution, 0.5% moxifloxacin hydrochloride ophthalmic solution and 0.3% gatifloxacin ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2008
- Phase
- Phase 4
- 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
- Be willing and able to provide written informed consent and HIPAA indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Be willing and able to follow all instructions and attend all study visits
- If female and of childbearing potential, not be pregnant, nursing or planning a pregnancy and agree to submit to a pregnancy test. The result of the test must be negative and female subjects of childbearing potential must also agree to use an acceptable method of contraception for the duration of the study (acceptable method of contraception includes oral, implantable, transdermal, or injectible contraceptives, spermicide with barrier, IUD, or surgical sterilization of partner)
Who cannot join
- Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the study
- Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
- Have a history of dry eye syndrome
- Use disallowed medications (systemic or topical) (i.e. any fluoroquinolone anti-infective agents or any topical ophthalmic products) during the appropriate pre-study washout period and during the study.
- Be a contact lens wearer who is unwilling to forego contact lens wear within 3 days prior to the start of the study and for the duration of the study
- Have had any ocular surgical intervention 12 months prior to the study or anticipate having ocular surgery during the study
Show all 9Show fewer
- Be pregnant or nursing women; or women who have a positive urine pregnancy test at screening or women of childbearing potential who refuse to use an adequate hormonal or mechanical means of birth control
- Be concurrently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of entry into this study
- Employees of the investigator or study center, with direct involvement in th proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to compare the concentration in human tears of levofloxacin and the active comparators at 15 minutes, 2,6, 12, and 24 hours after instillation of a single drop of medication.
- Conditions
- Healthy
- Being tested
- 1.5% levofloxacin ophthalmic solution, 0.5% moxifloxacin hydrochloride ophthalmic solution, 0.3% gatifloxacin ophthalmic solution
- Keywords
- Study drug concentration in human tears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5% levofloxacin ophthalmic solutionDrug
1 drop instilled at each visit
0.5% moxifloxacin hydrochloride ophthalmic solutionDrug
1 drop instilled at each visit
0.3% gatifloxacin ophthalmic solutionDrug
1 drop instilled at each visit
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | described in intervention Receives: Drug: 0.5% moxifloxacin hydrochloride ophthalmic solution |
| 3 | Active comparator | described in intervention Receives: Drug: 0.3% gatifloxacin ophthalmic solution |
| 1 | Active comparator | described in intervention Receives: Drug: 1.5% levofloxacin ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of levofloxacin, moxifloxacin or gatifloxacin in tears
Measured: 15 minutes, 2, 6, 12 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2008
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703313
- Sponsor's protocol ID
- VPH0108
- Status last verified
- Feb 2009
- First submitted
- 19 Jun 2008
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Availability in Human Tears After Topical Administration of 1.5% Levofloxacin Compared to Active Comparators
- ClinicalTrials.gov ID
- NCT00703313
- Acronym / sponsor ID
- VPH0108
- Conditions
- Healthy
- Keywords
- Study drug concentration in human tears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- First posted
- 23 Jun 2008 (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 primary objective of this study is to compare the concentration in human tears of levofloxacin and the active comparators at 15 minutes, 2,6, 12, and 24 hours after instillation of a single drop of medication.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: 0.5% moxifloxacin hydrochloride ophthalmic solutiondescribed in intervention |
| 3 | Active comparator | Drug: 0.3% gatifloxacin ophthalmic solutiondescribed in intervention |
| 1 | Active comparator | Drug: 1.5% levofloxacin ophthalmic solutiondescribed in intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be willing and able to provide written informed consent and HIPAA indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Be willing and able to follow all instructions and attend all study visits
- If female and of childbearing potential, not be pregnant, nursing or planning a pregnancy and agree to submit to a pregnancy test. The result of the test must be negative and female subjects of childbearing potential must also agree to use an acceptable method of contraception for the duration of the study (acceptable method of contraception includes oral, implantable, transdermal, or injectible contraceptives, spermicide with barrier, IUD, or surgical sterilization of partner)
Key exclusion criteria (9 listed)
- Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the study
- Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
- Have a history of dry eye syndrome
- Use disallowed medications (systemic or topical) (i.e. any fluoroquinolone anti-infective agents or any topical ophthalmic products) during the appropriate pre-study washout period and during the study.
- Be a contact lens wearer who is unwilling to forego contact lens wear within 3 days prior to the start of the study and for the duration of 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 |
|---|---|---|
| 1.5% levofloxacin ophthalmic solution1 drop instilled at each visit | Drug | 1 |
| 0.5% moxifloxacin hydrochloride ophthalmic solution1 drop instilled at each visit | Drug | 2 |
| 0.3% gatifloxacin ophthalmic solution1 drop instilled at each visit | Drug | 3 |
Primary outcome
Concentration of levofloxacin, moxifloxacin or gatifloxacin in tears
Time frame: 15 minutes, 2, 6, 12 and 24 hours
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 6 Feb 2009.
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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 1.5% levofloxacin ophthalmic solution, 0.5% moxifloxacin hydrochloride ophthalmic solution and 0.3% gatifloxacin ophthalmic solution in people with Healthy, run by Santen Inc. 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 9 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 6 Feb 2009. 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?
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 levofloxacin, moxifloxacin or gatifloxacin in tears (time frame: 15 minutes, 2, 6, 12 and 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 6 Feb 2009.