CataractsPhase 4NCT01296191
Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
A Phase 4 study testing Moxifloxacin and besifloxacin in people with Cataracts, run by Frank A. Bucci, Jr., M.D. at 1 site in United States.
Trial summary
The purpose of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataracts
- What is being tested?
- Moxifloxacin and besifloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jan 2013
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman 18 years of age or older.
- Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
- Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
- Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Subjects 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 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.
- Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
- History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
- Use of disallowed therapies (systemic or topical):
- Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
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- Use of contact lenses for one week prior to the study and for the duration of the study.
- Received an experimental drug or used an experimental medical device within 10 days before the planned start of treatment.
- Breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702
About this study
The purpose of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.
Read the detailed description
The objective of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance or VIGAMOX in subjects undergoing cataract surgery. The hypothesis of the study is that the aggregate aqueous absorption of Besivance over a six hour period is greater than VIGAMOX because of unique properties of Besivance which promote increased contact time of this antibiotic with the ocular surface.
Subjects with scheduled cataract surgery will be screened during their pre-operative visit. Eligible subjects will be randomized to treatment with Besivance or VIGAMOX. Subjects will self-administer 1 drop of study drug into the operative eye 4 times a day for 3 days prior to surgery.Subjects will have one final drop of study medication on the day of surgery.Immediately prior to beginning the cataract surgery, a sample of aqueous humor will be collected by paracentesis.Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration-time data will minimally include the area under the curve and the maximum concentration.
- Conditions
- Cataracts
- Being tested
- Moxifloxacin, besifloxacin
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Also called Vigamox
One drop 4 times daily for 3 days and one drop the day of sample collection
besifloxacinDrug
Also called Besivance
One drop 4 times daily for 3 days and one drop on day of sample collection
| Study group | Role | What they receive |
|---|---|---|
| VIGAMOX | Active comparator | Subjects undergoing cataract surgery, randomized to the VIGAMOX group Generic name is moxifloxacin eye drops, drops to be used 1 drop 4 times daily for 3 days prior to surgery and 1 drop on day of surgery. Receives: Drug: Moxifloxacin |
| Besivance | Active comparator | Subjects scheduled for cataract surgery, randomized to the Besivance group Generic name is besifloxacin eye drops, drops to be used 1 drop 4 times daily for 3 days prior to surgery and 1 drop on day of surgery. Receives: Drug: besifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics in Aqueous Humor Samples.
Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.
Measured: Measured after 3 days of drug instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completionJan 2013
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 CataractsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank A. Bucci, Jr., M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute
- Investigators
- Frank A. Bucci, Jr., MD, Principal investigator, Bucci Laser Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296191
- Sponsor's protocol ID
- 2011-BV-A
- Status last verified
- Nov 2020
- First submitted
- 14 Feb 2011
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
- ClinicalTrials.gov ID
- NCT01296191
- Acronym / sponsor ID
- 2011-BV-A
- Conditions
- Cataracts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Frank A. Bucci, Jr., M.D.University, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Posted 29 Oct 2019
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 compare drug concentrations in aqueous humor following ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.
Detailed description
The objective of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance or VIGAMOX in subjects undergoing cataract surgery. The hypothesis of the study is that the aggregate aqueous absorption of Besivance over a six hour period is greater than VIGAMOX because of unique properties of Besivance which promote increased contact time of this antibiotic with the ocular surface.
Subjects with scheduled cataract surgery will be screened during their pre-operative visit. Eligible subjects will be randomized to treatment with Besivance or VIGAMOX. Subjects will self-administer 1 drop of study drug into the operative eye 4 times a day for 3 days prior to surgery.Subjects will have one final drop of study medication on the day of surgery.Immediately prior to beginning the cataract surgery, a sample of aqueous humor will be collected by paracentesis.Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration-time data will minimally include the area under the curve and the maximum concentration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIGAMOX | Active comparator | Drug: MoxifloxacinSubjects undergoing cataract surgery, randomized to the VIGAMOX group Generic name is moxifloxacin eye drops, drops to be used 1 drop 4 times daily for 3 days prior to surgery and 1 drop on day of surgery. |
| Besivance | Active comparator | Drug: besifloxacinSubjects scheduled for cataract surgery, randomized to the Besivance group Generic name is besifloxacin eye drops, drops to be used 1 drop 4 times daily for 3 days prior to surgery and 1 drop on day of surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman 18 years of age or older.
- Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
- Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
- Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
Key exclusion criteria (9 listed)
- Known allergy or 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.
- Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
- History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
- Use of disallowed therapies (systemic or topical):
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 |
|---|---|---|
| MoxifloxacinAlso: VigamoxOne drop 4 times daily for 3 days and one drop the day of sample collection | Drug | VIGAMOX |
| besifloxacinAlso: BesivanceOne drop 4 times daily for 3 days and one drop on day of sample collection | Drug | Besivance |
Primary outcome
Pharmacokinetics in Aqueous Humor Samples.
Time frame: Measured after 3 days of drug instillation
Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Frank A. Bucci, Jr., MD principal investigator
Bucci Laser Vision 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 and besifloxacin in people with Cataracts, run by Frank A. Bucci, Jr., M.D. 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 6 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 22 Dec 2020. 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 29 Oct 2019). 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?
Pharmacokinetics in Aqueous Humor Samples. (time frame: Measured after 3 days of drug instillation). 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 22 Dec 2020.