Cataract ExtractionPhase 1NCT00824070
Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
A Phase 1 study testing Besifloxacin hydrochloride, moxifloxacin hydrochloride and gatifloxacin in people with Cataract Extraction, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation 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 Extraction
- What is being tested?
- Besifloxacin hydrochloride, moxifloxacin hydrochloride and gatifloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2009
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
- Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.
Who cannot join
- Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
- Subjects who had any corneal refractive surgery in the study eye.
- Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
- Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
- Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
- Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
- Subjects who are monocular.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
About this study
Official title: An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose
This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.
- Conditions
- Cataract Extraction
- Being tested
- Besifloxacin hydrochloride, moxifloxacin hydrochloride, gatifloxacin
- Keywords
- Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Besifloxacin hydrochlorideDrug
Also called Besivance
Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
moxifloxacin hydrochlorideDrug
Also called Vigamox
Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
gatifloxacinDrug
Also called Zymar
Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
| Study group | Role | What they receive |
|---|---|---|
| Besifloxacin | Experimental | Besifloxacin ophthalmic suspension Receives: Drug: Besifloxacin hydrochloride |
| Moxifloxacin | Active comparator | Vigamox (moxifloxacin ophthalmic solution, 0.5%) Receives: Drug: moxifloxacin hydrochloride |
| Gatifloxacin | Active comparator | Zymar (gatifloxacin ophthalmic solution, 0.3%) Receives: Drug: gatifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Aqueous Humor Drug Concentration.
An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
Measured: Visit 2, 1-14 days following screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionAug 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.
- 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 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Donnefeld, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824070
- Sponsor's protocol ID
- 575
- Status last verified
- Dec 2011
- First submitted
- 15 Jan 2009
- Last updated
- 13 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose
- ClinicalTrials.gov ID
- NCT00824070
- Acronym / sponsor ID
- 575
- Conditions
- Cataract Extraction
- Keywords
- Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 29 Oct 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 assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Besifloxacin | Experimental | Drug: Besifloxacin hydrochlorideBesifloxacin ophthalmic suspension |
| Moxifloxacin | Active comparator | Drug: moxifloxacin hydrochlorideVigamox (moxifloxacin ophthalmic solution, 0.5%) |
| Gatifloxacin | Active comparator | Drug: gatifloxacinZymar (gatifloxacin ophthalmic solution, 0.3%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
- Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.
Key exclusion criteria (7 listed)
- Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
- Subjects who had any corneal refractive surgery in the study eye.
- Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
- Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
- Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
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 |
|---|---|---|
| Besifloxacin hydrochlorideAlso: BesivanceInstill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. | Drug | Besifloxacin |
| moxifloxacin hydrochlorideAlso: VigamoxInstill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. | Drug | Moxifloxacin |
| gatifloxacinAlso: ZymarInstill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. | Drug | Gatifloxacin |
Primary outcome
The Aqueous Humor Drug Concentration.
Time frame: Visit 2, 1-14 days following screening visit
An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- 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.
Eric Donnefeld principal investigator
Ophthalmic Consultants of Long Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Besifloxacin hydrochloride, moxifloxacin hydrochloride and gatifloxacin in people with Cataract Extraction, run by Bausch & Lomb Incorporated 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 13 Dec 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
The Aqueous Humor Drug Concentration. (time frame: Visit 2, 1-14 days following screening visit). 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 13 Dec 2011.