Corneal TransplantationPhase 4NCT00764582
Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery
A Phase 4 study testing 1.5% levofloxacin ophthalmic solution and 0.5% moxifloxacin ophthalmic solution in people with Corneal Transplantation, run by Santen Inc. at 8 sites in United States.
Trial summary
Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (PK) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Transplantation
- What is being tested?
- 1.5% levofloxacin ophthalmic solution and 0.5% moxifloxacin ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2008to Mar 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman 18 years of age or older
- Scheduled for corneal transplant surgery
- Patients must be healthy enough to undergo surgery
- Women must be postmenopausal for at least 1 year or surgically sterile incapable of pregnancy
- Women must be abstinent at the discretion of the investigator
- Women practicing an effective method of birth control
- Women agree before entry to continue to use the same method of contraception throughout the study
- Women of childbearing potential must have a negative urine pregnancy test at screening
Who cannot join
- Presence of an active ocular infection or positive history of ocular herpetic infection
- History of severe dry eye syndrome
- Use of contact lenses in the 2 weeks prior to the study and for the duration of the study
- Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
- Pregnant or breast feeding
- Employees of the investigator or study center with direct involvement in the 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Boynton Beach, Florida
Study site
Cincinnati, Ohio
Study site
Great Rapids, Michigan
Study site
Indianapolis, Indiana
Study site
Kansas City, Missouri
Study site
Portland, Oregon
Study site
Springfield, Missouri
Study site
Stony Brook, New York
About this study
Official title: A Randomized, Observer-masked, Parallel-group, Multicenter Trial Evaluating the Ocular Penetration of 1.5% Levofloxacin Ophthalmic Solution and 0.5% Moxifloxacin Ophthalmic Solution in Subjects Undergoing Corneal Transplant Surgery
Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (PK)
- Conditions
- Corneal Transplantation
- Being tested
- 1.5% levofloxacin ophthalmic solution, 0.5% moxifloxacin ophthalmic solution
- Keywords
- Corneal penetration of levofloxacin and moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5% levofloxacin ophthalmic solutionDrug
Also called IQUIX
Topical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group.
Group 1: 30 minutes prior to surgery
Group 2: 1 hour prior to surgery
Group 3: 2 hours prior to surgery
Group 4: 4 hours prior to surgery
0.5% moxifloxacin ophthalmic solutionDrug
Also called VIGAMOX
Topical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group.
Group 5: 30 minutes prior to surgery
Group 6: 1 hour prior to surgery
Group 7: 2 hours prior to surgery
Group 8: 4 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 1.5% levofloxacin ophthalmic solution |
| 2 | Active comparator | Not described Receives: Drug: 0.5% moxifloxacin ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of levofloxacin and moxifloxacin in the corneal tissue
Measured: Time of surgery
Secondary outcomes (1)
Adverse Events
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009 (estimated)
Why it stopped: Study terminated due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vistakon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764582
- Sponsor's protocol ID
- VPH0109
- Status last verified
- Aug 2009
- First submitted
- 26 Sep 2008
- Last updated
- 26 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-masked, Parallel-group, Multicenter Trial Evaluating the Ocular Penetration of 1.5% Levofloxacin Ophthalmic Solution and 0.5% Moxifloxacin Ophthalmic Solution in Subjects Undergoing Corneal Transplant Surgery
- ClinicalTrials.gov ID
- NCT00764582
- Acronym / sponsor ID
- VPH0109
- Conditions
- Corneal Transplantation
- Keywords
- Corneal penetration of levofloxacin and moxifloxacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of enrollment.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vistakon Pharmaceuticals
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (estimated)
- First posted
- 2 Oct 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.
Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (PK)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 1.5% levofloxacin ophthalmic solution |
| 2 | Active comparator | Drug: 0.5% moxifloxacin ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Man or woman 18 years of age or older
- Scheduled for corneal transplant surgery
- Patients must be healthy enough to undergo surgery
- Women must be postmenopausal for at least 1 year or surgically sterile incapable of pregnancy
- Women must be abstinent at the discretion of the investigator
Key exclusion criteria (6 listed)
- Presence of an active ocular infection or positive history of ocular herpetic infection
- History of severe dry eye syndrome
- Use of contact lenses in the 2 weeks prior to the study and for the duration of the study
- Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
- Pregnant or breast feeding
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 solutionAlso: IQUIXTopical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group. Group 1: 30 minutes prior to surgery Group 2: 1 hour prior to surgery Group 3: 2 hours prior to surgery Group 4: 4 hours prior to surgery | Drug | 1 |
| 0.5% moxifloxacin ophthalmic solutionAlso: VIGAMOXTopical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group. Group 5: 30 minutes prior to surgery Group 6: 1 hour prior to surgery Group 7: 2 hours prior to surgery Group 8: 4 hours prior to surgery | Drug | 2 |
Primary outcome
Concentration of levofloxacin and moxifloxacin in the corneal tissue
Time frame: Time of surgery
1 secondary outcome
Adverse Events
Time frame: 4 days
Results and safety
The study was stopped early (reason given: Study terminated due to lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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.
8 sites 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 and 0.5% moxifloxacin ophthalmic solution in people with Corneal Transplantation, run by Santen Inc. at 8 sites 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 6 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: stopped early, as of the sponsor's last update on 26 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was stopped early (reason given: Study terminated due to lack of enrollment.). Results are not available in the source record.
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 and moxifloxacin in the corneal tissue (time frame: Time of surgery). 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 26 Aug 2009.