CataractsPhase 4NCT01296542
A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery
A Phase 4 study testing Moxifloxacin Ophthalmic and Besifloxacin Ophthalmic in people with Cataracts, run by Bucci Laser Vision Institute at 1 site in United States.
Trial summary
To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataracts
- What is being tested?
- Moxifloxacin Ophthalmic and Besifloxacin Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 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 years and older
- 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.
- 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 21 days before the planned start of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification
To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.
- Conditions
- Cataracts
- Being tested
- Moxifloxacin Ophthalmic, Besifloxacin Ophthalmic
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin OphthalmicDrug
Besifloxacin OphthalmicDrug
| Study group | Role | What they receive |
|---|---|---|
| VIGAMOX | Active comparator | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection Receives: Drug: Moxifloxacin Ophthalmic |
| Besivance | Active comparator | Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection Receives: Drug: Besifloxacin Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days
Lid and Conjunctival cultures will be taken to measure bacterial colonization.
Measured: Following 3 days of antibiotic drops topically instilled
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucci Laser Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT01296542
- Sponsor's protocol ID
- 2011-BV-C
- Status last verified
- Dec 2020
- First submitted
- 14 Feb 2011
- Last updated
- 8 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification
- ClinicalTrials.gov ID
- NCT01296542
- Acronym / sponsor ID
- 2011-BV-C
- Conditions
- Cataracts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bucci Laser Vision InstituteUniversity, 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 8 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIGAMOX | Active comparator | Drug: Moxifloxacin OphthalmicSubjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
| Besivance | Active comparator | Drug: Besifloxacin OphthalmicSubjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection |
Who may qualify
- Ages
- 18 years and older
- 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 (8 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 |
|---|---|---|
| Moxifloxacin Ophthalmic | Drug | VIGAMOX |
| Besifloxacin Ophthalmic | Drug | Besivance |
Primary outcome
Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days
Time frame: Following 3 days of antibiotic drops topically instilled
Lid and Conjunctival cultures will be taken to measure bacterial colonization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- 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.
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 Ophthalmic and Besifloxacin Ophthalmic in people with Cataracts, run by Bucci Laser Vision Institute 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 8 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 8 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 8 Dec 2020). 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?
Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days (time frame: Following 3 days of antibiotic drops topically instilled). 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 8 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.