Cataract ExtractionPhase 4NCT00924729
Study of Ocular Penetration of Topically Administered Fluoroquinolones
A Phase 4 study testing Moxifloxacin 0.5% ophthalmic solution and Besifloxacin 0.6% ophthalmic suspension in people with Cataract Extraction, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Moxifloxacin 0.5% ophthalmic solution and Besifloxacin 0.6% ophthalmic suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have a visually significant cataract and are planning to have cataract surgery.
- Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board.
Who cannot join
- Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form.
- Subjects who signs of ocular infection or active inflammation in the study eye.
- Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome.
- Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol.
- Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study.
- Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating.
- Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, 21287
About this study
Official title: Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.
- Conditions
- Cataract Extraction
- Being tested
- Moxifloxacin 0.5% ophthalmic solution, Besifloxacin 0.6% ophthalmic suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin 0.5% ophthalmic solutionDrug
Also called Vigamox
Administer moxifloxacin study drug prior to cataract surgery.
Besifloxacin 0.6% ophthalmic suspensionDrug
Also called Besivance
Administer besifloxacin study drug prior to cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin 0.5% ophthalmic solution | Active comparator | Not described Receives: Drug: Moxifloxacin 0.5% ophthalmic solution |
| Besifloxacin 0.6% ophthalmic suspension | Active comparator | Not described Receives: Drug: Besifloxacin 0.6% ophthalmic suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous Humor Concentration of Study Drug
Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.
Measured: approximately 3 to 4 months
Secondary outcomes (1)
Disk Diffusion Assay of Collected Aqueous Humor
A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.
Measured: Approximately 3-4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter J. Stark, M.D., Principal investigator, The Wilmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924729
- Sponsor's protocol ID
- NA_28692
- Status last verified
- Sep 2017
- First submitted
- 5 Jun 2009
- Last updated
- 24 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
- ClinicalTrials.gov ID
- NCT00924729
- Acronym / sponsor ID
- NA_28692
- Conditions
- Cataract Extraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Posted 11 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin 0.5% ophthalmic solution | Active comparator | Drug: Moxifloxacin 0.5% ophthalmic solution |
| Besifloxacin 0.6% ophthalmic suspension | Active comparator | Drug: Besifloxacin 0.6% ophthalmic suspension |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have a visually significant cataract and are planning to have cataract surgery.
- Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board.
Key exclusion criteria (7 listed)
- Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form.
- Subjects who signs of ocular infection or active inflammation in the study eye.
- Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome.
- Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol.
- Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results 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 |
|---|---|---|
| Moxifloxacin 0.5% ophthalmic solutionAlso: VigamoxAdminister moxifloxacin study drug prior to cataract surgery. | Drug | Moxifloxacin 0.5% ophthalmic solution |
| Besifloxacin 0.6% ophthalmic suspensionAlso: BesivanceAdminister besifloxacin study drug prior to cataract surgery. | Drug | Besifloxacin 0.6% ophthalmic suspension |
Primary outcome
Aqueous Humor Concentration of Study Drug
Time frame: approximately 3 to 4 months
Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.
1 secondary outcome
Disk Diffusion Assay of Collected Aqueous Humor
Time frame: Approximately 3-4 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Walter J. Stark, M.D. principal investigator
The Wilmer Eye Institute
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 Moxifloxacin 0.5% ophthalmic solution and Besifloxacin 0.6% ophthalmic suspension in people with Cataract Extraction, run by Johns Hopkins University 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 7 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 24 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Aqueous Humor Concentration of Study Drug (time frame: approximately 3 to 4 months). 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 24 Oct 2017.