CataractPhase 4NCT00630019
Ocular Tissue Levels of 1.5% Levofloxacin Ophthalmic Solution Compared to an Active Comparator
A Phase 4 study testing 1.5% levofloxacin ophthalmic solution and 0.5% moxifloxacin hydrochloride ophthalmic solution in people with Cataract, run by Santen Inc. at 1 site in United States.
Trial summary
Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- 1.5% levofloxacin ophthalmic solution and 0.5% moxifloxacin hydrochloride ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of instilling eye drop
- Scheduled for cataract surgery with intraocular lens (IOL) implantation
- Be medically cleared for surgery
- Women must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry, and must agree 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.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Subjects (or his/her legally acceptable representative) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Who cannot join
- Known allergy or other contraindication to the test article(s) or their components.
- Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
- History of or presence of any corneal pathology or disease
- Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
- History of severe dry eye syndrome.
- History or evidence of previous ocular surgery in the operative eye.
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- History of any significant illness that could be expected to interfere with the study parameters.
- Use of disallowed therapies (systemic or topical):
- Fluoroquinolone anti-infective agents (systemic or topical) within 2 weeks of Visit 1 or anytime after Visit 1 for the duration of the study;
- Topical ophthalmic preparations (including tear substitutes and rewetting drops), within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study (other than the study medication as restricted above), with the exception of non-steroidal topical ophthalmic drops
- 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.
- Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
- 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
1 site in 1 country.
United States1 site
Bucci Laser Vision & Ambulatory Surgery Center
Wilkes-Barre, Pennsylvania, 18702
About this study
Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.
- Conditions
- Cataract
- Being tested
- 1.5% levofloxacin ophthalmic solution, 0.5% moxifloxacin hydrochloride ophthalmic solution
- Keywords
- Aqueous humor penetration by anti-infectives
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5% levofloxacin ophthalmic solutionDrug
Topical application
0.5% moxifloxacin hydrochloride ophthalmic solutionDrug
Topical application
| 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 hydrochloride ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of levofloxacin and active control in the aqueous humor
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 posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- 96 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
- NCT00630019
- Sponsor's protocol ID
- VPH0107
- Status last verified
- Feb 2009
- First submitted
- 22 Feb 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 Tissue Levels of 1.5% Levofloxacin Ophthalmic Solution Compared to an Active Comparator
- ClinicalTrials.gov ID
- NCT00630019
- Acronym / sponsor ID
- VPH0107
- Conditions
- Cataract
- Keywords
- Aqueous humor penetration by anti-infectives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vistakon Pharmaceuticals
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- First posted
- 6 Mar 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 ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.
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 hydrochloride ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Capable of instilling eye drop
- Scheduled for cataract surgery with intraocular lens (IOL) implantation
- Be medically cleared for surgery
- Women must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry, and must agree 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.
Key exclusion criteria (15 listed)
- Known allergy or other contraindication to the test article(s) or their components.
- Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
- History of or presence of any corneal pathology or disease
- Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
- History of severe dry eye syndrome.
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 solutionTopical application | Drug | 1 |
| 0.5% moxifloxacin hydrochloride ophthalmic solutionTopical application | Drug | 2 |
Primary outcome
Concentration of levofloxacin and active control in the aqueous humor
Time frame: Time of surgery
1 secondary outcome
Adverse Events
Time frame: 4 days
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 and 0.5% moxifloxacin hydrochloride ophthalmic solution in people with Cataract, 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 7 inclusion and 15 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 and active control in the aqueous humor (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 6 Feb 2009.